MAUDE Adverse Event Report: COOK, INC. REDO DOUBLE LUMEN TPN CATHETER SET; CATHETER, INTRAVASCULARM THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number C-TPNS-7.0D-65-REDO

Device Problem Leak/Splash (1354)

Patient Problem Surgical procedure, additional (2564)

Event Date 07/18/2014

Event Type  No Answer Provided  

Event Description

Approx 2 weeks ago a redo double lumen tpn catheter was placed in a (b)(6) male burn pt.The line developed a leak near the cuff which was tunneled under the skin.The redo tpn catheter was exposed under the tunneled skin tract, cut and removed from the pt's upper right side of the chest.A new tunneled line was then placed in the pt.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Expiration - unk as lot is unk.Add'l procedures for replacement are not labeled in the ifu.Leakage is not labeled in the ifu.Event eval: still under investigation.

• Brand Name: REDO DOUBLE LUMEN TPN CATHETER SET
• Type of Device: CATHETER, INTRAVASCULARM THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3998874
• MDR Text Key: 21806618
• Report Number: 1820334-2014-00359
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2014

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 Catalogue Number: C-TPNS-7.0D-65-REDO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 08/05/2014
• 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): Required Intervention
• Patient Age: 12 YR