MAUDE Adverse Event Report: COOK INC TURBO-JECT POWER INJECTABLE; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: radiology interventionalist.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a turbo-ject power injectable central venous catheter became torn during a picc line placement procedure on an unknown patient.Another like device was opened to complete the procedure successfully.The defective product was immediately discarded.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details has been requested, but is currently unavailable.
Event or Problem Description
In additional information, it was reported that the tear was located on the main catheter shaft.The failure occurred during the procedure.It was found after the device was placed in the patient, almost after procedure was done.Upon discovery, the device was immediately replaced with a new product.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex a investigation ¿ evaluation (b)(6) hospital (republic of korea) informed cook that on 22feb2022, the catheter in a turbo-ject power injectable picc (rpn: upicds-5.0-ct-otw-st-1110, lot: 13711580) was torn on the main shaft.The failure occurred during the procedure and was removed and replaced with a new device.The failed device was discarded due to covid-19 issues in 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 of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be completed.However, 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 13711580 found no nonconformances that could have contributed to the reported failure mode.One relevant nonconformance was associated with subassembly lot ic13134459 for a surface defect, in which the nonconforming product was scrapped.It should be noted that there were no other complaints associated with the final product lot number.The affected component is supplied to the manufacturer and cook required that the supplier investigate this occurrence.The raw material lots that were associated with cook lot 13711580 were investigated, and it was determined that all three lots had been inspected before leaving the supplier.Any nonconforming material identified was scrapped.The supplier was unable to determine a root cause with the limited information provided.There are no obvious indications that the manufacturing process contributed to the failure mode, potentially a thin wall section contributed, but that cannot be confirmed.Evidence gathered upon review of dmr, dhr, supplier investigation, 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.Cook also reviewed product labeling.The product ifu, [t_ctpiccotw_rev8] ¿turbo-ject over-the-wire peripherally inserted central venous catheters,¿ 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 turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.¿ 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 wit 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 the maximum flow rate is at or below that which is listed on the catheter.Dynamic and static pressure test results are shown in the following table.¿ precautions ¿if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.¿ instructions for use power injection procedure ¿4.Ensure adequate blood return and flush catheter thoroughly with the entire 10ml 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.¿ how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no returned product, and the results of our investigation, it was concluded that a component failure could have contributed to the reported event.It is possible that the catheter experienced more pressure than what was recommended; however, cook is unable to confirm this.The appropriate personnel have been notified.Per the risk assessment no further action is required.Cook 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: TURBO-JECT POWER INJECTABLE
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• 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: 13660829
• Report Number: 1820334-2022-00337
• Device Sequence Number: 11229907
• Product Code: LJS
• UDI-Device Identifier: 00827002561946
• UDI-Public: (01)00827002561946(17)230124(10)13711580
• Combination Product (Y/N): N
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1110
• Device Lot Number: 13711580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 03/22/2022; 01/20/2023
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/24/2022; 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown