MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN SILICONE CENTRAL VENOUS/HYPERALIMENTATION CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number C-HASTC-1250J-CANADA

Device Problems Fluid Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol_(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.

Event Description

The tunneled line was inserted. Four days later, it was noted that both red and blue lumens had 2 very small pin like holes in the catheter lumen. When the end user attempted to flush lumens, normal saline was noted leaking from the holes. The leaking initially difficult to see when the external clamp was open but when the clamp was clamped closed the leakage was present, saline sprays out of holes. The holes were proximal to the hub of the catheters but distal to the suture wings. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: TRIPLE LUMEN SILICONE CENTRAL VENOUS/HYPERALIMENTATION CATHETER SET
• 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: 6894875
• MDR Text Key: 87608877
• Report Number: 1820334-2017-03340
• Device Sequence Number: 1
• Product Code: FOZ
• 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

• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: C-HASTC-1250J-CANADA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial