MAUDE Adverse Event Report: COOK INC TURBO-JECT DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G34516
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).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 the white lumen of a turbo-ject double lumen over-the-wire power-injectable picc was found cracked and later completely broke off.The catheter was originally implanted in the patient on (b)(6) 2020.On (b)(6) 2020, the staff discovered that the "line of the white lumen" was cracked.The picc line was then clamped at a point above the crack, and the area was cleaned with a dressing.The oncologist was notified of the crack in the device.On (b)(6) 2020, the patient was being cared for by their mother and during "the course of the day's activities, the end of the white lumen of the picc" line had completely broken off.The patient was then sent to have their picc line replaced.The facility that reported this event reported 7 total instances of picc lines cracking at the point where the hub meets the extension tubing and requiring replacement, reported under patient identifiers: (b)(6).Additional information regarding patient/event information has been requested but is not currently available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: d10, h3.Investigation ¿ evaluation: it was reported by (b)(6) from the (b)(6)hospital that the white lumen of the picc cracked and completely fell off.The complaint device was reported to be a turbo-ject double lumen over-the-wire power-injectable picc (rpn: upicds-4.0-ct-otw-st-1111, lot number 13248656).The device was implanted on (b)(6) 2020.On (b)(6) 2020 the staff caring for the patient discovered that the line of the white lumen was cracked.The picc was clamped above the break.The area was cleaned and covered with a dressing.The patient¿s oncologist was notified of the event.The next day ((b)(6) 2020) during the day¿s activities and while the mother of the patient was providing care, the end of the white lumen completely separated.The separation occurred on (b)(6) 2020 around 14:00.The device was removed and replaced on (b)(6) 2020.The event was reported as one of a series of events from this customer.Despite multiple e-mail attempts to obtain additional information and a meeting request with the customer no additional information could be provided.A review of the complaint history, device history record, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned for evaluation.A photo was provided of an example of the failure mode that the customer had multiple instances of which identified that the leak occurred in the region where the clear extension tubing goes into the catheter hub.Cook has concluded that the device was manufactured to specification.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the device history record found no nonconformances associated with the device lot (13248656).A database search found no additional complaints associated with this device lot; however, the same customer reported 13 total instances of this failure mode on the same product family.There was no trend in lot number.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: warnings: the safe and effective use of turbo-ject picc lines with power injector pressure 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.Precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter maintenance: if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with a catheter locking solution.Note: if microclave or other needless adapters approved for saline only lock are used, saline only catheter lock may be used.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should be again be flushed with twice the indicated lumen volume using normal saline before reestablishing catheter lock.Strict aseptic technique must be adhered to while using and maintaining catheter.Instructions for use 10.Secure the catheter to the skin, dress in the standard fashion based on the information provided, inspection of the provided image, and the results of the investigation, a definitive cause for failure was not established.Cook was unable to rule out manufacturing, patient or caregiver inadvertent tension placed on the device, over tightening during the attachment of accessory (tubing) devices, tension placed on the device during adl¿s as a cause of this event.Appropriate measures have been taken to address this failure mode.A capa is currently open to address this failure mode.The appropriate personnel have been notified.Per the quality engineering 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.
Event or Problem Description
No additional patient/event information has been received since the previous medwatch report was sent.

• Brand Name: TURBO-JECT DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10844715
• Report Number: 1820334-2020-02102
• Device Sequence Number: 17064044
• Product Code: LJS
• UDI-Device Identifier: 00827002345164
• UDI-Public: (01)00827002345164(17)220731(10)13248656
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: G34516
• Device Catalogue Number: UPICDS-4.0-CT-OTW-ST-1111
• Device Lot Number: 13248656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention