MAUDE Adverse Event Report: COOK, INC. COOK TPN TRIPLE LUMEN TPN CATHETER SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number C-TPNS-8.0T-90

Device Problem Split (2537)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 06/16/2014

Event Type  Injury  

Event Description

As per problem statement: "patient suffered distress after the lines split due to the fact they had to have cannula in place while devices had to be repaired." two catheters were involved, one split at the triangle above the bifurcation, the second catheter split again once repair has been completed.The lines were clamped and repaired per manufacturer's guidelines.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• Brand Name: COOK TPN TRIPLE LUMEN TPN CATHETER SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3940851
• MDR Text Key: 17573173
• Report Number: 1820334-2014-00308
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/18/2014

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 Expiration Date: 12/01/2015
• Device Catalogue Number: C-TPNS-8.0T-90
• Device Lot Number: 3934910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2014
• Device Age: 18 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other