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

Model Number	G55884
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device name- turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set.(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The customer reported that the picc was found to be leaking eight days after implantation.It was removed and replaced with a peripheral iv catheter.Upon inspection, it was found to be cracked between the catheter and hub.No part of the device was left in the patient, and there were no further injuries aside from the replacement procedure.

• Brand Name: Turbo-Ject
• 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: 6875271
• Report Number: 1820334-2017-03117
• Device Sequence Number: 1323794
• Product Code: LJS
• UDI-Device Identifier: 00827002558847
• UDI-Public: (01)00827002558847(17)171216(10)NS6420713
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G55884
• Device Catalogue Number: UPICS-3.0-CT-OTW-1110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/19/2017
• Patient Sequence Number: 1