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

Catalog Number C-TPNS-3.0-65-REDO

Device Problem Material Puncture/Hole (1504)

Patient Problem Unspecified Infection (1930)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Additional information: patient information - the patient (b)(6) years of age weighing (b)(6) kg. Device return: some part(s) of the device will be returned for evaluation. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a redo single lumen tpn catheter set was used to repair a cook catheter delivering tpn and iron infusions. The cook catheter was said to have "popped" on (b)(6) 2018 during a saline flush, which caused a hole. The line was locked with heparin and a culture was taken. The culture tested positive for infection and antibiotic treatment was given. As reported, the patient did not require an additional procedure to replace the line as the line was repaired with the repair kit.

• Brand Name: REDO SINGLE LUMEN TPN 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8192167
• MDR Text Key: 131338646
• Report Number: 1820334-2018-03714
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/20/2021
• Device Catalogue Number: C-TPNS-3.0-65-REDO
• Device Lot Number: 9005428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2018 Patient Sequence Number: 1