MAUDE Adverse Event Report: COOK INC COOK TPN SINGLE LUMEN TPN CATHETER; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	C-TPN-4.0-65
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(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 complainant reported that the outer lumen of the single lumen tpn catheter separated and the inner lumen remained intact.It was also reported that the repair was difficult and 2 kits were required to do the repair since the guide wire would not pass.No adverse effects to the patient were reported as a result of this product problem.

• Brand Name: COOK TPN SINGLE LUMEN TPN CATHETER
• 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: 6869818
• Report Number: 1820334-2017-03041
• Device Sequence Number: 18953506
• Product Code: FOZ
• UDI-Device Identifier: 00827002018730
• UDI-Public: (01)00827002018730(17)161001(10)4568382
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2017

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 Catalogue Number: C-TPN-4.0-65
• 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: 09/15/2017
• Patient Sequence Number: 1