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U.S. Department of Health and Human Services

MedSun: Newsletter #52, September 2010

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Newsletter #52, September 2010

Articles

Huber Needles: Recall - Risk of Coring

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class I Recall of certain Huber needles that were determined by FDA testing to produce cores when inserted into ports. Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core travelling through blood vessels into the patient’s lungs.

Additional Information:

FDA MedWatch Safety Alert. Huber Needles: Recall - Risk of Coring. August 26, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224163.htm

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Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens

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FDA MedWatch Safety Alert

FDA and CDC have noted a progressive increase in the reports of bloodborne infection transmission over the past 10 to 15 years (primarily hepatitis B virus), resulting from the shared use of fingerstick and point-of-care (POC) blood testing devices.

Additional Information:

FDA MedWatch Safety Alert. Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens. August 26, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224135.htm

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INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow

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FDA MedWatch Safety Alert

There is a potential for failure of a pressure switch which may have an impact on the administration of INOMAX for inhalation to patients. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a replacement system.

Additional Information:

FDA MedWatch Safety Alert. INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow. August 23, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm223746.htm

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6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub

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FDA MedWatch Safety Alert

Some devices in the affected batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly. If either of these were to occur during use, a potentially life threatening episode of bleeding could occur.

Additional Information:

FDA MedWatch Safety Alert. French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub. August 13, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222397.htm

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Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication

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FDA MedWatch Safety Alert

Several peer-reviewed clinical studies report an increase in bloodstream infections following the introduction and use of positive displacement needleless connectors in healthcare facilities, as well as a reduction in infections after changing to another type of needleless connector. However, there is insufficient information to determine the magnitude of the risk of bloodstream infections with these devices as compared with other needleless connectors, or to determine whether the risk is associated with some or all positive displacement needless connectors.

Additional Information:

FDA MedWatch Safety Alert. Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication. August 11, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221988.htm

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Safety Investigation of Suspected Counterfeit Combat Application Tourniquets (C-A-T): Initial Communication

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FDA MedWatch Safety Alert

FDA has become aware of suspected counterfeit C-A-T® tourniquets. The suspected counterfeit tourniquets have subtle differences in stitching, printing of the logo and molding of plastic parts. They may be packaged and labeled for a distributor other than the authorized manufacturer or distributors listed above. Preliminary testing has shown that the suspected counterfeit tourniquet does not perform the same as the tourniquet manufactured by Composite Resources.

Additional Information:

FDA MedWatch Safety Alert. Safety Investigation of Suspected Counterfeit Combat Application Tourniquets (C-A-T): Initial Communication. August 9, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221706.htm

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Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use

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FDA MedWatch Safety Alert

The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

Additional Information:

FDA MedWatch Safety Alert. Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use. August 9, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.htm

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Staff empowerment to 'stop the line'; reduces patient identification errors

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SafetyShare newsletter, Premier healthcare alliance

Patient misidentification continues to be a quality and safety issue, with minimal data describing interventions to reduce identification band error rates. At one hospital, ID band errors were reduced from a rate of 20.4 percent to an average mean rate of 2.6 percent with a combination of strategies suggested by leadership and frontline staff, including data display using control charts and the clear expectation to "stop the line" if patient identification error was suspected.

Additional Information:

SafetyShare newsletter, Premier healthcare alliance. Staff empowerment to "stop the line" reduces patient identification errors. August 2010.
http://www.premierinc.com/safety/safety-share/07-10-full.jsp#Story-1-Patient-Id

FDA Patient Safety News. Dangerous Confusion with Color-coded Wristbands. June 2006.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=52#8

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LabNet

Safe Sharps Handling

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Lab Manager Magazine

Two of the most common causes of needle sticks are re-capping needles and improper disposal of needles. All needle sticks, and other sharps injuries, carry the risk of secondary infections in addition to exposure to the needle's content and/or contamination on the outside of the needle or other sharp instrument. Recommendations for avoiding these injuries are included.

Additional Information:

Lab Manager Magazine. Safe Sharps Handling. July 1, 2010.
http://www.labmanager.com/stips.asp?ID=126

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Updated Guideline for using interferon gamma release assays to detect mycobacterium tuberculosis infection

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CDC MMWR

This report provides guidance to U.S. public health officials, health-care providers, and laboratory workers for use of FDA-approved IGRAs in the diagnosis of M. tuberculosis infection in adults and children. In brief, TSTs and IGRAs (QFT-G, QFT-GIT, and T-Spot) may be used as aids in diagnosing M. tuberculosis infection. They may be used for surveillance purposes and to identify persons likely to benefit from treatment. Multiple additional recommendations are provided that address quality control, test selection, and medical management after testing.

Additional Information:

CDC MMWR. Updated Guideline for using interferon gamma release assays to detect mycobacterium tuberculosis infection. June 25, 2010.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5905a1.htm

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Clostridium difficile: Navigating the testing options for diagnosis

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AACC Clinical Laboratory News

The diagnosis of CDI remains difficult, and there is no one best test that fits everyone's needs. With new testing methods, epidemic strains, evolving epidemiology and ever growing economic constraints, it is challenging to know which assay to use. EIA alone is often the least expensive option. Two-step algorithms with GDH as the front-end test work well in low-prevalence populations. Molecular tests appear to be more sensitive than non-molecular tests, but the cost is prohibitive for many laboratories. The choice for an individual laboratory should be based on careful evaluation of a selected test in your unique setting.

Additional Information:

AACC Clinical Laboratory News. Clostridium difficile: Navigating the testing options for diagnosis. July 2010.
http://www.aacc.org/publications/cln/2010/july/Pages/SeriesArticle.aspx

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HeartNet

Guide wire fracture during percutaneous transluminal coronary angioplasty: Possible causes and Management

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Interact CardioVasc Thorac Surg

The HeartNet team is highlighting a recently published article in Interactive Cardiovascular and Thoracic Surgery which presents the possible causes and management for guide wire fractures during percutaneous transluminal coronary angioplasty.

MedSun has recently received a cardiovascular event report that describes issues with guidewire fractures. The following report illustrates this issue.

Additional Information:

Interact CardioVasc Thorac Surg. Guide wire fracture during percutaneous transluminal coronary angioplasty: Possible causes and Management. February 2010.
http://icvts.ctsnetjournals.org/cgi/content/full/10/6/992

Interact CardioVasc Thorac Surg 2010;10:992-994. doi:10.1510/icvts.2009.227678
http://icvts.ctsnetjournals.org/

MedSun Report. July, 6, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1769199

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HomeNet

Well@Home Monitor - Class II recall

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FDA CDRH Recalls

The Well@Home Monitor by Patient Care technologies is intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis. The touch panel on affected devices may become unresponsive.

Additional Information:

FDA CDRH Recalls. Well@Home Monitor – Class II recall. August 3, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91006

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KidNet

Baby Matters Recalls Nap Nanny Recliners Due to Entrapment, Suffocation and Fall Hazards; One Infant Death Reported

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U.S. Consumer Product Safety Commission

The U.S. Consumer Product Safety Commission (CPSC), in cooperation with Baby Matters LLC, of Berwyn, Pa., is announcing the voluntary recall of 30,000 Nap Nanny portable baby recliners. CPSC is investigating a report of an infant who died in a Nap Nanny that was being used in a crib. According to preliminary reports, the infant was in the harness and found hanging over the side of the product, caught between the Nap Nanny and the crib bumper.

Additional Information:

U.S. Consumer Product Safety Commission. Baby Matters Recalls Nap Nanny® Recliners Due to Entrapment, Suffocation and Fall Hazards; One Infant Death Reported. July 26, 2010.
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10309.html

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Preventing Catheter/Tubing Misconnections: Much needed help is on the way

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ISMP Medication Safety Alert!

Luer connector systems, common to many healthcare catheters, tubes, administration sets, extension sets, and syringes, have been at the heart of many catheter/tubing misconnections. At the center of one of the most commonly reported problems is the fact that some manufactured enteral catheters still have ports that only accept parenteral administration sets and syringes. So, even if a liquid medication is prepared in an oral syringe, the medication must be transferred to a parenteral syringe for administration via this type of enteral catheter port, risking the accidental administration of the drug via a parenteral line.

Additional Information:

Preventing Catheter/Tubing Misconnections: Much needed help is on the way. ISMP Medication Safety Alert! July 15, 2010.
http://www.ismp.org/Newsletters/acutecare/articles/20100715.asp

On July 9, 2010, FDA sent a letter to product manufacturers, healthcare practitioners, and hospital purchasing departments that offered advice regarding the prevention of catheter/tubing misconnections:

www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM218631.pdf

FDA Luer Misconnections
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm134863.htm

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NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a recall of two lots of NeoProfen (ibuprofen lysine) Injection because the product failed to meet a visible particulate quality requirement. NeoProfen is a non-steroidal anti-inflammatory therapy indicated to close a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The recall includes product lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012).

Additional Information:

FDA MedWatch Safety Alert. NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter. August 2, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220798.htm

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SightNet

Webcast: Medical Device Event Reporting in Ophthalmic Settings

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Please visit the Educational Materials page for a newly posted webcast entitled, Medical Device Event Reporting in Ophthalmic Settings sponsored by SightNet and presented in June of 2010.

Presentation slides and audioconference transcripts are available for this webcast. A direct link to this program may be found under Additional Information below.

Additional Information:

Medical Device Event Reporting in Ophthalmic Settings. June 9, 2010. FDA MedSun Website: Educational Materials. Posted September 2010.
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm223427.htm

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period June 1 through June 30 2010. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


CARDIOVASCULAR

Device:
Type: Hemodynamic Monitor System
Manufacturer: McKesson Information Solutions LLC, McKesson Israel LTD
Brand: Horizon Cardiology
Cat #: CE-TCSHEM003

Problem:
Patient was brought to cath lab for emergent temporary pacemaker. Monitor technician initiated the Horizon cardiology program for monitoring the patient and documenting the case. System failed to initialize. An error message appeared "Internal". IS was contacted, but they were unable to resolve issue. McKesson support was also contacted for assistance. Situation not resolved until case completed. All documentation and vital signs done manually. No harm to the patient.


Device:
Type: Kit, Catheter, Intra-aortic Balloon
Manufacturer: Arrow Internation
Brand: Fiberoptix
Model#: IAB-05840-LWS
Lot #: MF0042502
Cat #: IAB-05840-LWS

Problem:
Patient needed an intra-aortic balloon. The balloon was then prepped and inserted into the femoral artery through the provided arterial sheath with a side arm. The balloon had a lot of resistance going through the provided sheath. The physician attempted to remove the balloon from the sheath, but the balloon had been damaged beyond use. The balloon was unable to be removed from the sheath, so the balloon catheter was removed along with the sheath. A second balloon was prepped. The package comes with two different sheaths and the other sheath with no side arm was used for balloon placement without any further complications. The patient had no apparent injury.

Manufacturer provided RGA# for product return evaluation and provided shipping container.


Device:
Type: Monitor System, Telemetry
Manufacturer: GE Healthcare
Brand: Apexpro
Other #: Software 5.1

Problem:
Patient had a 12 beat run of Vtach which did not alarm on the monitoring system. The event was observed by the Cardiac Arrhythmia Technician. The physician was notified, labs drawn, and treatment administered as ordered without further incident.

Manufacturer response: GE is responsive and analyzing strips. Conference call planned.


Device:
Type: System, Thermal Regulating
Manufacturer: Cincinnati SubZero
Brand: Blanketrol Ii

Lollipop Icon

Problem:
Infant in NICU receiving hypothermia therapy to minimize brain injury. Infant noted to have a core temperature of less than the expected 33.5°C. Infant was assessed. Cooling blanket was assessed and found to be set at "5°C Manual." It had not been switched to "33.5°C Automatic." Infant's core temperature dropped to 30°C. She was re-warmed after blanket was reset to "33.5°C Automatic." Infant's heart rate decreased to 69 bpm, no dysrhythmias were noted.

While reviewing instruction manual for setup instructions, it was noted that the need to switch from "5°C Manual" to "33.5° C Automatic" was not written clearly.


Device:
Type: Lead, Defibrillation
Manufacturer: Medtronic, Inc.
Brand: Sprint Fidelis
Model #: 6949-65cm

Problem:
The patient called the office stating that his ICD was beeping, advised patient to send in a Carelink transmission which showed noise on the RV lead indicating a possible fracture of the lead. The patient was then advised to come into the office. The patient was scheduled for an explant two days later. The lead was explanted and a new lead implanted. The patient did really well.
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Health Professional's Impression
======================
The fracture in the lead caused the ICD device to think pt was having or have had some ventricular arrhythimas leading to a possible shock from the device.

Comment from FDA: Physician practices are now partnering with the MedSun program. This report was received from a physician's practice.


Device 1:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1003254
Cat #: 1741-003

Device 2:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1003114
Cat #: 1741-003

Device 3:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 0912234
Cat #: 1741-003

Device 4:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1004134
Cat #: 1741-003

Device 5:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1005034
Cat #: 1741-003

Device 6:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1003294
Cat #: 1741-003

Device 7:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1003024
Cat #: 1741-003

Device 8:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 0908140
Cat #: 1741-003

Device 9:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 0908104
Cat #: 1741-003

Lollipop Icon

Problem:
Some of ConMed Neotrode II neonatal/Pediatric ECG Electrodes have failed out of the packaging. Over a month period our facility has reported 36 failures on 9 different lot numbers and manufacturing dates. The staff are reporting poor ECG signals or no signal and lots of artifact. The problem was identified by doing an x-ray of some of the electrodes and our Clinical Engineering staff using their meters to perform continuity tests. Defective electrodes can't be identified visually. Failure point of the electrode is where the patch is connected to wire, a failure to bond or weld correctly. In talking to ConMed about this problem, they informed us they have researched this problem and have determined that the failure is due to a malfunction of a machine that assembles these electrodes. We were informed the machine was repaired and is functioning properly. Product manufactured before 05/03/2010 could be problematic, which is consistent with our findings of multiple lot number and manufacturer dates. The manufacturer is in process of replacing problematic product. The affected product was returned to ConMed. All product was returned and all lot numbers. Our facility has return a total of 13 unopened cases, and around 7 open cases of product that was pulled back from departments when new product was delivered here at our facility. ConMed is process of replacing all stock at all 9 hospitals in our corporation.
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Health Professional's Impression
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Multiple failures, lots of frustration from staff, before finding product that would work correctly. Sometime opening six packages before find a good set of ECG lead wires.
======================
Manufacturer response for Neonatal / Pediatric ECG Electrode Set, Neotrode II
======================
Conmed has investigated the recent situation (based on recent complaints) and has determined that there is no reason (from a quality /safety perspective) to have product returned from the field. The situation appears to be intermittent and infrequent (with no risk to the patient and or/ clinicians). We have performed all of the necessary steps to ensure that we are providing the most appropriate response (in regards to federal requirements and regulations). As a proactive step to ensure performance of our products, we implemented additional tests and inspections throughout the manufacturing process (implemented in early May).


CLINICAL CHEMISTRY

Device:
Type: Calculator/data Processing Module, For Clinical Use;
Manufacturer: Cerner
Brand: Bridge Specimen Collection System
Other #: Zebra label printer

Problem:
Specimen label from the Bridge Specimen Collection System printed label with Patient A and CPI, but with a bar coded accession number and test that belonged to a previously printed Patient B. The laboratory automation line caught and rejected the erroneous specimen label and no erroneous results were reported on the either patient.
======================
Manufacturer response for Cerner's Bridge Specimen Collection system:
Cerner suggested a patch that "cleans up" label files when ever the application is "abruptly interrupted", such as loss of wireless connectivity, etc. They believe this will prevent the "incomplete label record" from "Patient A" from ever being available for "Patient B". We moved that code into production; no new incidents have been reported.


GENERAL & PLASTIC SURGERY

Device:
Type: Bipolar Forceps
Manufacturer: Ascent
Brand: Pks Cutting Forceps
Model#: 920005PK
Lot #: 1063059
Other #: 5 mm diameter

Problem:
A reprocessed Ascent handpiece did not function as the doctor expected it to when engaged. The device was expected to cauterize and then cut, but it did not cut. The device was sent to Ascent, the reprocessor, and they found fault with the handling of this device and they are correcting their process. All similar product was returned to Ascent.
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Health Professional's Impression
======================
If it did not cauterize and then cut, there would be potential blood loss and delay of surgery for device replacement.


Device:
Type: Newborn Heel Incision Device
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Brand: Tenderfoot
Lot #: BB062
Other #: 1.0mm length 2.5mm

Lollipop Icon

Problem:
The nurse was performing a heel stick on an infant. She opened the Tenderfoot device and removed the safety lock. The infant's heel had been prepped. The RN placed the device on the heel and activated it by pushing the slide bar. Normally, the device would auto-lance the infant's heel. However, in this instance, the device split open and the lancing device came out of the side instead of at the opening in the bottom of the device. The infant and RN were not hurt. However, had the RN been holding the device in a different way, the RN could have been cut by the lancet. The RN obtained another device and drew the infant's blood. The RN's on the unit have not had this experience with this type of device before. All are experienced users. Prior to using the device, there was no indication that the device would fail or was faulty in any way. No unusual or excessive force/pressure was applied to the device.
======================
Health Professional's Impression
======================
Staff does not know why the device failed or what could have caused it to do so.
======================
Manufacturer response for Tenderfoot Heel Incision Device
======================
We are awaiting instructions to return the device to the manufacturer for their investigation and analysis.


Device:
Type: System, Ablation, Microwave
Manufacturer: Medwaves
Brand: Medwaves Microwave Generator
Model#: MWG881

Problem:
During a tumor ablation, the microwave antenna treatment delivered a lower energy than what was displayed on screen. Patient was not harmed but required a repeat treatment.


GENERAL HOSPITAL

Device:
Type: Catheter, Implanted, Port
Manufacturer: AngioDynamics
Brand: Vortex Mp Port
Model#: Vortex MP-P5SAT
Lot #: 504544

Lollipop Icon

Problem:
During the procedure to implant Vortex MP Port (size 5 French) in the chest, and with very little manipulation of the catheter, the catheter broke off at the junction of the metal lock. The rest of the catheter completely separated. This is the second time within the last couple of months that we have seen this kind of failure. In this case, the catheter was pre-attached. The catheter broke, and upon inspection the catheter was very brittle, and easy to break with very little force. The risk is if it went undetected and/or broke off after implant, then it could cause catheter embolization.


Device:
Type: Catheter, Picc
Manufacturer: Becton Dickinson
Brand: Bd 2. 6French
Model#: unk
Lot #: 7114730, 9113195, 9063169,
Cat #: 384466
Other #: lot number 9063769

Lollipop Icon

Problem:
A 2.6 French dual lumen BD catheter was placed. Eight days later the catheter was noted to have leakage from the blue port at the bifurcation, but then stopped. Two days later at noontime, the blue port again was noted to be leaking at the bifurcation. The infant was also noted to be febrile and had an elevated white count. After extensive team discussion, the decision was made to clamp off the blue port and use as a single lumen. Later on that day at 1600, the red port was noted to be leaking. A decision was made to remove line. Patient currently has a single lumen broviac used for parental nutrition/intralipids, dopamine, opioid infusion, and has an 8 French left internal jugular hemodialysis catheter. Additional access was required for triple antimicrobial coverage and sedation. After eight attempts, a peripheral IV was placed in the right foot. There have been recent incidences of leaking of BD dual lumen catheters elsewhere in the hospital over the past few months for which a practice alert had been sent. At that time NICU CNS checked all lot numbers in unit and confirmed lot numbers were not included in those reported as defective. A decision was made not to remove given that there was no available replacement of appropriate size.

Remove BD dual lumen catheters from NICU supply, both 2.6 and 3.5 French. Continue search for appropriate alternative product. Discuss at NICU meeting.

See device image:
2.6 French dual lumen BD catheter experienced leakage from the blue port at the bifurcation.  This image shows where leaking occurred.


Device:
Type: Catheter, Picc, Stylet
Manufacturer: Bard Access Systems, Inc
Brand: 5Fr Powerpicc With Sherlock Tip Location System (Tls) Stylet
Lot #: REUA1183

Problem:
A female patient was admitted with respiratory and cardiac issues. A PICC (peripherally inserted central line) was inserted, and a routine post insertion chest film revealed what appeared to be a 6 cm wire fragment in her axilla vein. The wire fragment is presumed to be from the tip of the stylet wire used to insert the catheter. An interventional radiologist physician removed the wire fragment without difficulty.


Device 1:
Type: Bed, Ac-powered
Manufacturer: KCI USA, Inc.
Brand: Barimaxx Ii Bed With Maxxair Ets Mattress Replacement

Device 2:
Type: Mattress, Air Flotation
Manufacturer: KCI USA, Inc.
Brand: Maxxair Ets Mattress

Problem:
We have had 2 safety events of airway compromise related to the use of the KCI BariMaxx II bed with the MaxxAir ETS Mattress Replacement System. The mattress is not supported by a battery back up and when the bed was unplugged for transport the mattress deflated causing a shift in the patient's position in bed. This shift in patient position resulted in mechanical compromise of the airway.
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Health Professional's Impression
======================
The lack of a battery back up to maintain mattress inflation resulted in deflation of the mattress to the 3 inch foam surface below, causing a shift in position resulting in airway compromise.


Device 1:
Type: Software, Documentation And Charting
Manufacturer: McKesson Information Solutions, LLC
Brand: Horizon Clinicals
Other #: Horizon Clinicals Version 10.1.1.2 with HED Version .225

Device 2:
Type: Physiological Monitor, Database Server
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: M3154
Cat #: Software Version, K.00.27
Other #: Other servers running versions E.01.26 to K.00.27 - all with same problem

Problem:
This event is not patient specific, rather it is a software interaction problem involving Philips Intelliview Patient Monitor System and McKesson Horizon Clinical Charting System. Issue is that readings of NIBP do not always chart the correct NIPB value when the Horizon Clinical application is set to filter or chart the value every 15, 30, 60, etc. minutes.

Our problem is that the NIBP value that shows up in McKesson Horizon Clinicals is the value from a measurement taken 15 minutes earlier.

Example: Clinician starts an NIBP reading after setting the Philips Intelleview Monitor (in this case an MP70) to take an NIBP measurement every 15 minutes. The Clinician pushing the NIBP start button at 11:55. The Intelliview monitor starts the inflation of the cuff, then starts deflating, then displays the value. The time now is 11:57. At 12:00 McKesson Horizon Clinicals performs a query and receives the NIBP value. Everything is good, values are correct.

The problem now starts. The Philips Intelliview monitor will, over time, round up the NIBP start time to the quarter hour (this is a built in feature of the software the user cannot disable). So for example, an hour later, instead of the NIBP starting at say 12:55, it will now start the NIBP measurement at 1:00. Also at 1:00, McKesson Horizon Clinicals is set to querying for NIBP data from Philips which at this exact point in time has not completed the NIBP measurement and thus still has the value from the 12:45 NIBP measurement. The NIBP measurement starts at the quarter hour but does not have a value until the measurement has completed which might take anywhere from 45 seconds to 3 minutes depending on if the monitor has to retry 2 or 3 times, etc.

In critical care areas patients are monitored closely for the efficacy of medication administration, especially vasoactive drugs. A delayed reading of blood pressure could lead the bedside nurse to adjust the dosage of medication incorrectly, leading to possible serious injury or even death.

Our Biomed dept is unable to find a solution to the DAS problem working with either manufacturer, Philips and McKesson. The following is from an e-mail communication with Philips Support:
Customer has concerns about the way Philips system sends NIBP data via HL7 to McKesson charting system.

He has a large server network with 5 DBS and 1 Patient Link with MPx monitors. The MPx monitors are configured for auto NIBP measurements every 15 minutes. The McKesson system queries the DBS or PL once every minute, however it applies a filter to the NIBP data so that the nurses view it on the charting system only in 15 minute intervals.

The problem is the MPx monitor starts the NIBP clock when the pump starts, but it may sometimes take a minute or two to actually get a reading (due to patient-related or application issues). During that time McKesson would have queried for the data and received it but may not be able to display in the nurses 15 minute view because of that 1-2 minute lag.

As a workaround, the customer has disabled the external time source at the master DBS and has manually offset the time 1-2 minutes ahead at the master DBS to compensate for the time discrepancy of the NIBP measurements.

The customer is suggesting that the MPx monitor be modified so that once it detects an active HL7 connection, it should start the NIBP pump 1-2 minutes earlier so that the data is not missed on the display view at the McKesson charting system.

The customer has also received feedback from customer support at other non-Philips sites that (another) vendor's monitors do not have this problem because they allow you to offset the NIBP start time a little bit.



Device:
Type: Thermometer Probe Covers
Manufacturer: Welch Allyn, Inc.
Brand: Welch Allyn Probe Covers
Lot #: 0107 6
Cat #: 05031
Other #: 706486-C

Problem:
The RN noticed that the individual box of thermometer probe covers do not indicate whether or not there is latex present in the product. If preparing a room for a patient with a latex allergy, the staff would not know if the covers had latex in them unless they called Central Stores. The large container that the boxes are delivered in indicates that there is no latex in the product, but the end user has no way of knowing this from the information that is printed on the individual containers. This was brought to the attention of the manufacturer. Staff suggest that a label indicating 'no latex' or 'latex free' be printed on the individual probe cover boxes.
======================
Health Professional's Impression
======================
the manufacturer only prints 'latex free' on the large shipping box, not on each individual product box.
======================
Manufacturer response for thermometer probe covers, Welch Allyn probe covers
======================
We recommended to the manufacturer that they consider labeling each individual box with the phrase 'latex free'.


HEMATOLOGY


Device 1:
Type: Analyzer, Chemistry
Manufacturer: ITC
Brand: Hemochron Signature Elite
Model#: Signature Elite

Device 2:
Type: Analyzer, Chemistry
Manufacturer: ITC
Brand: Hemochron Signature Elite
Model#: Signature Elite

Device 3:
Type: Analyzer, Chemistry
Manufacturer: ITC
Brand: Hemochron Signature Elite

Problem:
Test is used to determine clotting time prior to, during, and immediately after cardiac bypass. Test is also used during carotid vascular surgery. It measures clotting time to help clinicians know how much heparin to give pt's to prevent clotting while blood flow is stopped or impeded by surgery. Clinicians have been getting widely variant results. When immediately repeated, results significantly different. At times, result is higher after no heparin, and at times, result does not increase with heparin as it should. Staff have been running two machines side by side and/or performed tests more frequently to try to treat the patient, but are unsure of the accuracy of their results. Staff has experienced problems since March. The problem was recently brought to attention of Risk Mgt. The manufacturer is aware and has already come in to observe practice. The mfr made recommendations for change in practice with anesthetists to align with what perfusionists were doing. Staff still experiencing variant results after adjusting testing procedure. The company has taken one of three machines back for evaluation, and provided one loaner. Of the remaining two machines that remain in house the staff has experienced variant results on both machines. They do not record the serial # of the machine, so detailed incidents can not be attributed to each specific machine. Details of several incidents are being faxed to provide examples of what is happening.
======================
Manufacturer response for Coagulation System, Hemochron Signature Elite
======================
They have not yet come to observe what happens during a case to see what is happening.
======================
Manufacturer response for Coagulation system, Hemochron Signature Elite


MICROBIOLOGY

Device:
Type: Wound Culture Swab & Medium
Manufacturer: Remel
Brand: Bactiswab
Lot #: 862518
Cat #: 12100

Problem:
As the nurse crushed the culture medium vial, a sharp object came through the plastic tube that caused the nurse to cut his finger.


NEUROLOGY

Device 1:
Type: Agent, Injectable, Embolic
Manufacturer: Micro Therapeutics, Inc. Dba Ev3 Neurovascular
Brand: Onyx 18
Lot #: 8333559

Device 2:
Type: Catheter, Continuous Flush
Manufacturer: Micro Therapeutics, Inc. Dba Ev3 Neurovascular
Brand: Marathon
Lot #: 7489723
Other #: Microdelivery Marathon catheter,1.5F/013 inchX165 cmX25cm

Problem:
During Arterio-Venous Malformation (AVM) procedure, a microcatheter was used and Onyx 18 was injected in to the AVM. Upon attempt to remove the catheter, the Onyx adhered to the microcatheter and a piece of the microcatheter had to be broken off to get the catheter out. Approximately 12cm of the catheter was retained in the patient. It is estimated that the amount of Onyx reflux was approximately 1cm. Vasospasm is not thought to have contributed to the event. The patient experienced no complications in the immediate post procedure period, but on the following morning, did experience a syncopal event during ambulation. The patient then underwent infusion of thrombolytics, CT scan showed a possible right posterior intracerebral (IC) cerebrovascular accident (CVA). By the second day, post procedure, the patient had recovered full strength and was discharged home several days later. There are no plans to have the retained catheter surgically excised.


OPHTHALMIC

Device:
Type: Occular Cannula And Plug
Manufacturer: Alcon Research, LTD
Brand: Alcon Total Plus 23ga Vvtrectomy Pak
Lot #: 9023848X-2009-07
Cat #: 8065750828

Problem:
The patient was undergoing eye surgery. Normally during this kind of case, cannulas are inserted into the eye and are capped with plugs to maintain gas inflation of the eye. In this case, the plugs did not fit in the cannulas--they were too big. This is unusual, particularly since the cannulas and plugs all come together in one kit. The patient was not harmed by this event; however, the physician was quite frustrated. None of the staff involved in the event have ever had this experience before. Another kit from the same manufacturer and reference number was obtained and used for the case. The kit which contained plugs that did not fit the cannulas was saved and the rep was contacted. OR staff are coordinating the return of the device to the manufacturer.
======================
Health Professional's Impression
======================
The physician and staff believe that either the wrong size plugs or wrong size cannulas were placed into the same kit.
======================
Manufacturer response for occular cannula and plug, Alcon Total Plus 23ga vitrectomy pak
======================
OR staff called the rep on the day of the event. No further follow up has been received as of the filing of this report.


PHYSICAL MEDICINE

Device:

Type: Warm Pack
Manufacturer: Hospital Marketing Services, Co., Inc
Brand: Novation
Model#: V6001-047
Lot #: 7981-3

Problem:
The nurse was attempting to activate a heat pack for her patient. She squeezed the bag to pop the inner chamber and get the pack warming. However, the heat pack didn't warm up. She tried three--all with the same result. On the fourth try, she had one that did get warm. All four packs were from the same manufacturer, model and lot numbers. All of the heat packs are stored in the same area. We have seen this problem before. In the past, the manufacturer found a pin-hole size opening in the inner pouch. Staff suspect that this may be the cause for these packs not heating up.

We are awaiting the manufacturer's response. We will return the device to them for their investigation/analysis.


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Lollipop Icon Special Note:
The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events Involving Foley Catheters

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Conventional and antimicrobial Foley catheters are described in the FDA regulations under 21 CFR 876.5130(a), Urological Catheter and Accessories, as a "flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract." A Foley catheter has also been described as an indwelling balloon-retention catheter used by medical professionals to provide a means of bladder drainage through the urethra. The catheter is for single use, is intended for short-term (less than 30 days) use, and is retained in the bladder with a balloon inflated with a sterile liquid. Sterile water is generally recommended (1).

Over the past year, MedSun has received 27 adverse event reports associated with the Foley Catheter device manufactured by two firms, Bard and Covidien Kendall. The reports were submitted by 20 hospitals between August, 2009 and July, 2010.

The majority of the reported problems include the failure of the catheter’s balloon to deflate, failure to inflate, or failure to maintain inflation. When the balloon is not able to be deflated, the patient will experience discomfort and pain. This problem often requires surgery or a medical procedure to remove the catheter from the patient.

When inflation is not achieved with the device, or the device does not maintain inflation, the patient does not receive the intended therapy. The reported Foley Catheter problems are shown below:
• Balloon not deflating: 6
• Balloon not inflating( or staying inflated): 4
• Pieces of Catheter separated: 4
• Not draining urine: 2
• Difficulty removing Foley catheter: 4
• Unable to remove Foley after deflation: 1
• Catheter became Dislodged: 1
• Failure of temperature sensing probe: 1
• Cuffing of balloon: 1
• Balloon ruptured: 1
• Torn drainage bag: 1

There were no reported patient deaths in these reports. There were 10 instances of patient injuries listed in the 27 reports. The reported injuries are listed below:

• Procedure required to remove Foley catheter: 5
• Surgery required to remove catheter or (retained pieces of catheter): 2
• Pain to Perineum: 1
• Skin redness and sensitivity from excessive manipulation during Foley removal: 1
• Patient placed on antibiotics for difficult catheter removal: 1


Of the reports that listed patient age, 2 had a patient age listed as less than 21 years and 20 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 8 reports involved female patients and a total of 15 reports involved male patients.

The following table lists the MedSun reports that are described in the device problem summary above.


Adverse Event Table
DeviceDevice Identifiers Event Description
C.R. BARD Model# Cat# Lot# KJ8171, 303016A A Foley catheter was placed following a radical Cystoprostatectomy for management of an Orthotopic Ileal Neobladder. Six days later, the patient reported having severe pain in the penis while transferring from the hospital bed to a chair. Upon inspection by the nursing staff, the catheter was noted to be deflated and out of the patient. The catheter bulb torn from the catheter tip and the bulb was not located. The patient underwent an exploratory Cystogram and no remnants were noted to be retained in the patient. A new catheter was placed and the integrity of that catheter remained intact at discharge.
C.R. BARD Model# unknown Cat# 907116 Lot# unknown Foley catheter was placed in patient. When the balloon was deflated and removed from patient, cuffing was present that caused discomfort for the patient. We had a problem with the foleys earlier and we contacted bard. They gave us instructions to discontinue the practice of inflating the balloon prior to insertion. We re-educated staff and changed the practice, however the cuffing and discomfort with removal continued. We discarded all foleys from these lots and the problem continued with the new lots. The company told us it was a problem with our technique. We decided to change the brand of foley we were purchasing and to discontinue using bard. We have done this and have not had any further problems. The change happened a few months ago.
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL DOVER, 20Fr Model# unknown Cat# unknown Lot# 9075141 A 20 Fr Foley was placed in a patient as a Gastrostomy tube, due to unsuccessful attempts to advance Orogastric and Nasogastric tubes. The Foley was advanced through a small hole with 10 ml in the balloon to provide some counter pressure. The Gastrostomy tube, which was a Foley catheter, came out of the stomach and was in the space between the stomach and the abdominal wall. The tube balloon was not inflated. The balloon was checked and it was intact, unruptured, and without a leak. The patient's abdomen contained barium and tube feeds.
C.R. BARD LUBRI-SIL HYDROGEL-COATED SILICONE, 20Fr Model# unknown Cat# 909616M Lot# NC TE1167 A 20 Fr Foley was placed in a patient as a Gastrostomy tube, due to unsuccessful attempts to advance Orogastric and Nasogastric tubes. The Foley was advanced through a small hole with 10 ml in the balloon to provide some counter pressure. The Gastrostomy tube, which was a Foley catheter, came out of the stomach and was in the space between the stomach and the abdominal wall. The tube balloon was not inflated. The balloon was checked and it was intact, unruptured, and without a leak. The patient's abdomen contained barium and tube feeds.
C.R. BARD LUBRI-SIL HYDROGEL-COATED SILICONE Model# unknown Cat# 909616M Lot# NC TE1167 A Foley catheter was used to measure the patient's bladder temperature. It was found to be consistently 36.3 degrees Celsius. For comparison, the temperature was measured with the probe and the oral temperature was found to be 37.0 degrees Celsius. Several additional measurements consistently showed the oral temperature to be 36.7-36.8 degrees Celsius. The representative for the manufacturer was contacted and he indicated that Foley temperature should be at least 0.5 degrees warmer than oral measurements, and not cooler. The temperature measured with the Foley catheter was nearly one degrees Celsius too low, which could mask a fever and preclude treatment.
C.R. BARD Model# unknown Cat# unknown Lot# unknown The Foley balloon does not properly inflate. The item was saved to return to Bard for a proper refund. The catheter was tested under sterile technique before being inserted into the patient. There was no patient contact or harm.
C.R. BARD BARDEX I.C. 16Fr Model# unknown Cat# unknown Lot# NG TB0537 A 16 Fr Foley catheter was inserted. The staff was unable to inflate the Foley catheter with the prefilled 10cc syringe of sterile water. Only 1 cc was used. After 30 minutes, the patient became very uncomfortable. Attempts to withdraw the fluid were unsuccessful. The catheter was cut, and required a guide wire to deflate the balloon
C.R. BARD LUBRICATH Model# unknown Cat# 0165L16 NE8037 Lot# unknown The patient had a Foley catheter placed during gynecological surgery. Upon removal, only 8-10 cc of clear fluid could be withdrawn from the balloon port. Another 10 cc of saline was injected, but it also could not be withdrawn. The balloon port was cut and only a few drops of clear liquid ran out. The Foley was removed by a physician and the balloon was found to be slightly inflated. There was no patient harm.
C.R. BARD Model# unknown Cat# 897216 Lot# NGTE1354 An order was received to discontinue the Foley catheter. The catheter balloon was deflated, and the staff began withdrawing the catheter. Resistance was encountered and the procedure was stopped. A syringe was used to withdraw from the balloon port again. There was no fluid left in the balloon and the catheter could not be removed. The MD had to withdraw the catheter past the point of resistance, which was very uncomfortable as per the patient. When the MD was able to remove the catheter, we noted a "cuff" remained at the balloon. The purchasing manager notified Bard and removed all lot # ngte1354’s from service. The purchasing manager also spoke with the Bard quality control rep. whose response was "that can be a factor with the silicon product."
COVIDIEN Model# unknown Cat# 8887605205 Lot# 9075141 The catheter was inserted in surgery and fell out in the recovery room after the balloon split and ruptured.
C.R. BARD BARDEX I. C. COMPLETE CARE Model# unknown Cat# 903016A Lot# NGTH0974 The Foley catheter was checked prior to patient use and the balloon would not inflate. The inflation occurred in the pigtail where the syringe was inserted, before it got to the main part of the catheter. It looks like the spot where the pigtail goes into the main part of the catheter does not have an opening. When attempting to inflate balloon, the catheter inflated at the instillation port.
C.R. BARD Model# unknown Cat# 8000062 Lot# 365718 This was a confused patient with padded mitts on his hands secondary to pulling at tubes. The nurse entered room to find part of the patient's catheter attached to the drainage bag in the bed. Approximately six inches of the catheter was missing. The catheter had torn with a jagged edge. The patient required surgical removal of the remaining six inch piece of catheter from his bladder.
C.R. BARD LUBRICATH/16 FR COUNCIL TIP Model# unknown Cat# unknown Lot# unknown The urinary catheter balloon deflated spontaneously and the catheter fell out of the patient. A crack was noticed in the catheter near the inflation port. When retesting the balloon after the catheter fell out, water leaked from the crack.
C.R. BARD LUBRI-SIL IC Model# unknown Cat# 300916A Lot# unknown These temperature sensing Foleys are a new product for our hospital. This version is silicone with a silver polymer coating for antimicrobial action. A leak developed and the Foley catheter had to be replaced. There has been more than one event with this problem of having instances of the tip becoming clogged at the duct hole. Another problem is with the probe becoming loose and dangling. These catheters are smaller than the non-silicone product. We had an instance in the ICU where three patients had no urine output. It was determined that the catheters were clogged, and this was not related to the patient's renal status.
C.R. BARD Model# unknown Cat# 1758S Lot# unknown While removing patient's Foley catheter, the tip became stuck at the tip of the patient's penis (the urethral opening). The catheter had to be manipulated and tugged and the patient experienced discomfort. The tip of the patient's penis was red and sensitive after removal was finally achieved. This catheter was the type that is inserted in the OR. There is a hard plastic ring that remains after the balloon is fully deflated. The ring is at the tip of the catheter. Other catheters do not have this hard plastic ring at the tip of them (they are smooth and they do not get caught at the tip of the penis). The catheter was saved and is in the patient's room for inspection.
C.R. BARD Model# unknown Cat# unknown Lot# unknown The Patient had a Foley catheter in place. When the RN attempted to remove the catheter she was unable to deflate the balloon. After attempts by multiple team members, the balloon still would not deflate. In order to remove the Foley catheter, the patient was required to undergo an interventional radiology procedure. The balloon was injected with contrast, which flowed freely into the balloon, but could not be drained. The radiologist punctured the balloon through the patient's abdomen using a 22 gauge spinal needle. After this, the balloon deflated and the catheter was easily removed.
COVIDIEN Model# unknown Cat# unknown Lot# unknown This event was reported by the patient's urologist. The patient underwent a Cystoscopy and a transurethral resection of the prostate at the hospital. After the procedure, the following occurred as per the operative note. A 22-Fr three-way catheter was placed. Light traction was applied and the drainage was crystal clear. The patient went to the recovery room in stable condition. Eight days later, the MD reported to the surgery staff that the patient said his indwelling Foley snapped apart at home and was not caught on anything. A section was left in the patient's bladder. The MD reported that there was no serious harm. The MD did a Cystoscopy in the office to remove it. The patient is fine, per the MD.
C.R. BARD BARDEX Model# unknown Cat# 165808 Lot# unknown An 8 Fr Foley catheter was being removed from a pediatric patient with difficulty. The nurse called a physician to remove the catheter because it would not come out. Following removal, it was noted that the portion which is inflated after insertion and deflated before removal had a ridge. The sterile water had been removed from the balloon. Although removal was difficult, the patient did not sustain any injury. The staff were able to re-create this problem with other catheters of the same lot number.
C.R. BARD Model# unknown Cat# 165816 Lot# unknown The Foley catheter had been inserted during a hospital visit. The patient returned to the urologist's office to have Foley catheter removed. The nurse recalls that the physician drew back on the syringe while draining the balloon. This is contrary to the recommendations from the manufacturer. The physician attributed the problem to a defect in product. The vendor recommends additional in-service on proper techniques.
COVIDIEN Model# unknown Cat# 8887-665241 Lot# 9082389 A triple lumen catheter would not perform continuous bladder irrigation with several tries. The catheter was left in for urine drainage. The catheter is used for continuous bladder irrigation. It is a three port catheter: one for the balloon, one to allow fluid to install and one to allow drainage. The irrigation fluid would not run in. The operative note conveys the following: "a 22 three-way Foley catheter was placed indwelling, but continuous irrigation could not be accomplished despite various efforts. This was removed, and utilizing a catheter guide again, a 24 Foley 3-way catheter was placed, a Kendall polyethylene brand. Again, this could not be irrigated with continuous bladder irrigation. Ultimately the urine was clear enough that we abandoned the continuous bladder irrigation and left the catheter in place."
C.R. BARD BARDEX I.C. INFECTION CONTROL FOLEY CATHETERS Model# unknown Cat# 0165SI Catheter, 920016A Tray Lot# AE0263 The additional “Y” port on the side of the catheter is split in half where the “Y” joins the main catheter. The balloon would not have inflated and there was a possibility of exposure to infection because the sealed system was broken.
C.R. BARD TRAY, FOLEY Model# unknown Cat# 899616 Lot# NG UD0721 The Foley catheter was ordered to be removed. The nurse attempted to deflate the balloon with a syringe and could not. She cut off the hub of the balloon port and attempted to deflate the balloon by aspirating from the balloon port without the hub in place. This also did not work. She then phoned the urologist who attempted to deflate the balloon by inserting a stylet. This was unsuccessful. The urologist then inserted a needle with a syringe beneath the patient's scrotum to burst the balloon through the bladder wall. The catheter was then successfully removed. The nurse pulled another catheter kit, same lot number, and tested it, finding this balloon was also inflatable but could not then be deflated. The risk manager also tried another catheter, with the same lot number, and this balloon worked properly (able to inflate and deflate). There was an internal obstruction of some kind that allowed the inflation of the balloon but not deflation of the balloon.
C.R. BARD LATEX-FREE DRAINAGE BAG FOLEY Model# unknown Cat# 907216 Lot# nguc1924, ngud1854 A Bard Foley catheter was inserted in a patient. The balloon deflated and the catheter needed to be replaced. There was no harm to the patient. It was noted that over the weekend there were several problems with these particular catheter balloons deflating. The catheter trays being used were Bard product #907216, latex-free drainage bag Foley tray with anti-reflux chamber drainage bag, in size 16fr. Two lot numbers were identified as problems: nguc1924 and ngud1854. In addition, two other lot numbers were suspected of having similar problems. These were lot numbers nguc0365 and ngud1853. The balloon on the catheter leaked and deflated, causing the catheter to have to be replaced.
C.R. BARD BARDEX I.C. COMPLETE CARE Model# unknown Cat# unknown Lot# NG UD 1039 Upon testing the Foley bulb before insertion, the bulb inflated but did not deflate.
C.R. BARD. BARDEX I.C. COMPLETE CARE Model# unknown Cat# unknown Lot# unknown Foley balloon did not deflate after initial test. Foley did not come into contact with patient
C.R. BARD BARDEX I.C. COMPLETE CARE Model# unknown Cat# 408607 Lot# 970300 The balloon was inflated with 10cc's of sterile water to test the integrity. It would not deflate when the syringe was used to retract the 10cc's. The balloon remained inflated with water. Several attempts were made to deflate it unsuccessfully. The staff may not be following the mfr's suggestions for how to remove the fluid from the balloon. Pretesting before insertion is the practice here, but I am not sure if removal of the solution is performed the same way by all users. We will alert the education dept here for a possible review with all staff.
BARD UROLOGICAL DIVISION BARDEX I.C. COMPLETE CARE FOLEY TRAY W COLLECTION SYSTEM Model# unknown Cat# unknown Lot# unknown The nurse noted urine on floor. The urine meter bag was torn where the meter flips up to drain into the main bag. The tear is in the same place as a bag previously found to be leaking which was previously reported.
C.R. BARD FOLEY CATHETER Model# unknown Cat# unknown Lot# NGUE0836 A Foley catheter was inserted to the “Y” in the tubing and water was added. The Foley was pulled back until resistance was felt. The patient had a CT of the abdomen and the nurse was told the Foley was in the urethra. A 10cc syringe was used to remove the water so the Foley could be re-adjusted. The water would not drain. The catheter was cut and the water still did not drain. The MD was also unsuccessful in attempting to remove the water from the balloon. The urologist was called. Under ultrasound, a needle was inserted through the penis and into the balloon and then the water drained. The Foley was removed. The patient had Suprapubic catheter placed.

Additional Information:

1. The FDA Public Medical Device Database may be searched for an overview of these devices. This device can be search by visiting:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080884.htm

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Updated September 1, 2010

Return to MedSun: Medical Product Safety Network

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