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

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 05/10/2014

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported there was a hole in the picc line.It was also reported that repair challenges were encountered: difficult repair.

• Brand Name: COOK TPN SINGLE LUMEN TPN CATHETER
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6890815
• MDR Text Key: 87869156
• Report Number: 1820334-2017-03300
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002042612
• UDI-Public: (01)00827002042612(17)160901(10)4525052
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-TPN-3.0-55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1