MAUDE Adverse Event Report: COOK INC SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

Additional common name: ljs turbo-ject peripherally inserted central venous catheter.Additional product code: ljs.Occupation: other health care professional.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a spectrum turbo-ject antibiotic power injectable picc implanted in a (b)(6) female patient for the iv administration of fluids and medications, was found to be leaking both fluid and blood.The mother of the patient pressed the call light and reported that the patient's line was leaking.Upon entering the room, the nurse discovered maintenance iv fluid dripping from the picc line.The tubing and connections were found to be secured, yet fluid was leaking as the infusion continued.Approximately 5ml of fluid was noted on the floor.The nurse then delayed the pump, detached the tubing from the patient and capped the infusing iv line in order to identify the location of the fluid leak.As soon as the nurse detached the current infusion, a small amount of blood began leaking out of the line.The nurse then grabbed atraumatic clamps from a drawer and clamped one in the middle of the clave and another where the line was sutured in.As blood leakage continued slowly, the nurse removed the clamp below the bottom of the dressing.This caused the leakage to stop.A small hole was noted 5cm above the clave.The charge nurse was called to look at the line and later discussed future options with the physician.The nurse stayed at the bedside to ensure that the clamp would stay in place.The team of physicians quickly made the decision to have the picc line pulled, which the nurse carried out shortly after.Minimal fluid was found where the patient was sitting, which indicated that the line probably broke not long after the patient's mother pressed the call light.The mother was noted to have been with the patient the entire time.It was reported that the nurse had been in the room 15 minutes prior and confirmed that there were no issues with the line.It was later noted that approximately 3ml of blood leaked from the line by the time the nurse got the atraumatic clamp placed in the correct location.It is currently unknown how the line developed a hole.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information received on 07mar2022.It was reported that the picc line was initially placed on (b)(6) 2021.The line was not replaced, as a peripheral iv was used to administer medication following picc removal on (b)(6) 2021.It was confirmed that no unintended sections of the device remained in the body of the patient.The patient did not require hospitalization or prolonged hospitalization due to this occurrence.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Correction: h6 - annex a.Investigation / evaluation: (b)(6) hospital (united states) informed cook that on (b)(6) 2021, a spectrum turbo-ject antibiotic power injectable picc (rpn: upics-3.0-ct-nt-abrm-1110, lot: 13724268) was leaking.The picc line was placed on (b)(6) 2021 and was later removed on (b)(6) 2021.The device was not replaced.The patient required a peripheral iv placement for medication during the admission to the hospital.It was reported that the patient did not have any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu) and quality control procedures, as well as a visual inspection and functional test of the returned unused devices, were conducted during the investigation.The complaint device was not returned for evaluation; however, the customer returned six unused devices from the same lot.Functional tests of the devices found no evidence of leaks or occlusions.The hubs and connections were found to be secure.No additional issues with the devices were noted.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot: 13724268, as well as subassembly and raw material lots, found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were five other complaints associated with the final product lot number, in which all complaints fall under a previous capa investigation that found that the product issue is related to device design.Cook also reviewed product labeling.The product ifu (t_upicabrm_rev2) ¿cook spectrum turbo-ject peripherally inserted central venous catheters with micropuncture peel-away introducers¿ provides the following information to the user related to the reported failure mode: intended use: ¿the maximum pressure limit setting for power injectors used with the spectrum turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the masimum flow rate indicated, as shown on the following table.¿ warnings: ¿the safe and effective use of turbo-ject picc lines with power injector pressures set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.To safely use turbo-ject picc lines with a power injector, the technician/health care professional must verify prior to use that the maximum pressure limit is set at or below 325 psi and that the maximum flow rate is at or below that which is listed on the catheter.Dynamic and statis pressure test results are shown in the following table.[3fr single hub has a 0.52 ml priming volume, 2ml/sec labeled flow rate, 123 psi maximum flow, 249 psi 37 degrees celsius average static burst water pressure, 237-258 psi 37 degrees celsius range static burst pressure.] maximum flow rate pressures are determined with pump safety cut-off set at 325 psi, using contrast media with a viscosity of 11.8 cp.Static burst pressure is the failure point of the catheter when totally occluded.Warning: power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.¿ precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Patient movement can case catheter tip displacement.Catheters places via an antecubital vein have shown tip movement of up to 10 cm with motion of the extremity.Catheter size should be as small as the use will allow.Instructions for use: power injection procedure: ¿2.Remove any injection/needless caps from the spectrum turbo-ject picc.3.Attach a 10ml (or larger) syringe filled with sterile normal saline to the hub of the extension tube to be used for power injection.4.Ensure adequate blood return and flush catheter vigorously with the entire 10 ml of sterile normal saline to ensure lumen patency.Warning: failure to ensure patency of the catheter lumen prior to injection may result in catheter failure.5.Remove syringe and attach power injection device to the catheter using the manufacturer¿s recommendations.6.Conduct study using the power injector, making sure not to exceed the maximum flowrate or pressure limit for the catheter.7.Disconnect the power injection device and flush the catheter again with 10 ml of sterile normal saline.8.Place a new injection/needeless cap on the spectrum turbo-ject picc, flush and lock the catheter with saline or heparinized saline per institutional protocol.¿ how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if packaging is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, and device failure analysis, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of the returned product and the results of our investigation, a previous capa investigation found that the root cause is related to device design.The investigation further found that the devices were manufactured to specification with no evidence of lot-related issues.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13588610
• MDR Text Key: 287590703
• Report Number: 1820334-2022-00302
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002056763
• UDI-Public: (01)00827002056763(17)221201(10)13724268
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2022

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 Expiration Date: 12/01/2022
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-NT-ABRM-1110
• Device Lot Number: 13724268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/07/2022; 10/21/2022
• Supplement Dates FDA Received: 03/11/2022; 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Female