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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. TEMPERATURE SENSING FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. TEMPERATURE SENSING FOLEY CATHETER Back to Search Results
Model Number 129416M
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that four temperature sensing foley catheters were occluded over time.The drainage lumen slowly closed over a few days of use.Customer could not get any fluid through the drainage lumen.A new catheter was placed into the 4 patients and each worked fine for their duration.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿biological deposits".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use: (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients: · patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients: (1) patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter." h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that four temperature sensing foley catheters were occluded over time.The drainage lumen slowly closed over a few days of use.Customer could not get any fluid through the drainage lumen.A new catheter was placed into the 4 patients and each worked fine for their duration.
 
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Brand Name
BARDEX I.C. TEMPERATURE SENSING FOLEY CATHETER
Type of Device
TEMPERATURE SENSING FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key12054015
MDR Text Key257964575
Report Number1018233-2021-03752
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741039775
UDI-Public(01)00801741039775
Combination Product (y/n)N
PMA/PMN Number
K040658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number129416M
Device Catalogue Number129416M
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/01/2021
Initial Date FDA Received06/23/2021
Supplement Dates Manufacturer Received07/29/2021
Supplement Dates FDA Received08/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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