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

Catalog Number	UPICDS-4.0-CT-NT-1111
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: no code available - additional procedure required to replace line.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 a turbo-ject® double lumen power-injectable picc hub was found cracked where the line extension tubing meets the hub.Additional patient and event information have been requested but not provided.As reported, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Additional information: additional information was received (b)(6) 2018 which identified the problem on this catheter was also leakage where the line extension meets the hub.Device evaluation the device was not returned for evaluation.However, a document based investigation evaluation was performed.Investigation a document-based investigation reviewed the following: instructions for use, quality control specifications, complaint history and device history records.There is no evidence to suggest the finished product was not made to specifications.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.A review of the device history record of the finished product shows no nonconforming events.A complaint history search revealed there was one other reported complaint for this lot number for fitting, damaged.Risk assessment determined that risk controls are in place to mitigate this failure mode.The appropriate personnel were notified, and we will continue to monitor for similar complaints.Appropriate measures have been initiated to investigate this failure mode.Conclusion based on the information provided, no return of the product, and the results of our investigation, a definitive root cause could not be determined.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.
Additional Manufacturer Narrative
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
A sus voluntary report, mw5080167, was received on 25oct2018 and reconciled with this case.

• Brand Name: TURBO-JECT® DOUBLE 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: 7923022
• Report Number: 1820334-2018-02803
• Device Sequence Number: 13849408
• Product Code: LJS
• UDI-Device Identifier: 00827002345140
• UDI-Public: (01)00827002345140(17)200622(10)8972600
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2019
• Report Date (Section F): 10/25/2018

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: 06/22/2020
• Device Catalogue Number: UPICDS-4.0-CT-NT-1111
• Device Lot Number: 8972600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 12/17/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/21/2018; 01/17/2019
• 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
• Date Report Sent to FDA: 10/25/2018