MAUDE Adverse Event Report: COOK INC TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G12801
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported during the patient's picc line placement procedure, the wire guide appeared to kink, lodge/stick and was unable to be advanced any further.As a result, the wire guide was removed and another was used.It was noted the patient experienced adverse effects as a result of this event.However, no information was provided regarding what the adverse effects were.Additionally, device imaging identified bends and coil elongation within the wire guide.

• Brand Name: TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET
• 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: 6866399
• Report Number: 1820334-2017-03033
• Device Sequence Number: 1365140
• Product Code: LJS
• UDI-Device Identifier: 00827002128019
• UDI-Public: (01)00827002128019(17)180616(10)5964559
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G12801
• Device Catalogue Number: UPICS-501-MPIS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1