MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	G03265
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/19/2015
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
The doctor reported that there was difficulty removing the guide wire from the catheter after placement.Therefore, both the catheter and the guide wire were removed as one unit and replaced with a new kit (picc).The doctor stated that the kit was used according to the instructions.It was reported that when the doctor opened the first device, the catheter and the guide wire were separated; the cap used for handling the wire removal seemed undamaged.There was a small kink noted about 31.5 cm from the cap end (this was noted on the first device prior to use).The spirally wrapped wire was separated from the solid core, starting about 3 cm from the tip of the wire and the spirally wrapped wire was pulled straight/unraveled, according to the reporter this was noted on the first device prior to use.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6896837
• Report Number: 1820334-2017-03151
• Device Sequence Number: 16482333
• Product Code: FOZ
• UDI-Device Identifier: 00827002032651
• UDI-Public: (01)00827002032651(17)171229(10)5545130
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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: G03265
• Device Catalogue Number: C-PICS-301J
• 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: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1