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-3.0-55
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2014
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 complainant reported that the line "snapped where thick meets thin." the thick part of line was not covered with dressing.The repair itself was easy, but it was difficult to remove the sleeve off of the repair and it was partially torn.This was not noted until after the repair kit was on.They tried to put the 2nd splint on the torn area, but it didn¿t work so another repair was done 2 days later and 2 kits were used.It was difficult as the inner lumen kept bunching, but it finally worked.No adverse affects to the patient were reported as a result of the 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: 6864547
• Report Number: 1820334-2017-02999
• Device Sequence Number: 13653197
• Product Code: FOZ
• UDI-Device Identifier: 00827002042612
• UDI-Public: (01)00827002042612(17)170601(10)5031089
• 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): 09/14/2017

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 Catalogue Number: C-TPN-3.0-55
• 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: 09/14/2017
• Patient Sequence Number: 1