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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Edema (1820); No Code Available (3191)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: pharmacy assistant specialist.(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 patient required placement of a turbo-ject® single lumen power-injectable picc line in the arm.Five weeks later, it was noted there was a "product leak in the patient's arm causing an oedematous arm" which necessitated withdrawal of the picc line.Following withdrawal, it was observed that the picc line was cracked.The patient required a replacement device.Additional information regarding the event and patient outcome had been requested but is currently unavailable.
Additional Manufacturer Narrative
Additional information: d10 - product received on.Investigation - evaluation: a review of documentation including the device history record, complaint history, drawing, quality control and specifications, as well as a visual inspection of the returned device was conducted during the investigation.The visual inspection of the complaint device showed damage to the guide catheter.A hole in the catheter measuring 45 cm from the distal tip was observed and was found to be 1 cm in length.A severe kink was noted at the base of the manifold.Additionally, a document-based investigation evaluation was performed.Cook has concluded that the device in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.Furthermore, sufficient inspection activities are in place to identify this failure mode prior to distribution.The risk specification for this product includes the loss of use failure mode and identifies risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record for lot 9552830 found no nonconformances that could have contributed to this failure mode.It should be noted that there have been no other complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive root cause could not be established.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified.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 information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TURBO-JECT® SINGLE LUMEN 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: 8850836
• Report Number: 1820334-2019-01889
• Device Sequence Number: 259847
• Product Code: LJS
• UDI-Device Identifier: 00827002238978
• UDI-Public: (01)00827002238978(17)210228(10)9552830
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: UPICS-5.0-CT-NT-1111
• Device Lot Number: 9552830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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