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-5.0-65-REDO

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 12/01/2014

Event Type  Injury  

Event Description

The tpn catheter was inserted on (b)(6) 2014.The device separated on (b)(6) 2014; repaired with a 4fr repair kit.Then on (b)(6) 2014 reported the line cracked and was replaced on (b)(6) 2014 (1820334-2015-00007).Nothing detached inside of the patient.The catheter was removed and replaced with another manufacturer's 4.2 fr single during the same anesthetic.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

• 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; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4377107
• MDR Text Key: 5238934
• Report Number: 1820334-2015-00007
• 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: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Catalogue Number: C-TPNS-5.0-65-REDO
• Device Lot Number: F2681915
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2014
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other