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

Catalog Number C-TPNS-5.0D-65-12-RED

Device Problem Leak/Splash (1354)

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

Event Date 06/23/2014

Event Type  Injury  

Event Description

As per problem statement.After a couple of usages they have discovered leakage on the lumen outside the patient.Same problem on the two catheters.Additional information provided (b)(4) 2014.The patient got the cvc inserted on (b)(6) 2014 for antibiotic infusion therapy.The line was working properly and there was no problem with the infusion and the flushing.The antibiotics given were meronem 3 times/day, cymevene 2 time/day and ciprofloxacin 2cc/min during 1 h.After 14 days with no problem the small lumen ruptured in the extension 4-5cm from the hub.It ruptured during flushing with saline after the infusion therapy.This was the second time the device ruptured for this patient.The fitting was connected to a luer-lock syringe <10 cc, 3 way stop-cock or a cap.The device was in place for 14 days.There was no force exerted and no patient problems associated with rupture.The distal end of the catheter was still in place.It was surgically retrieved and there was inertion of a new cvc.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Add'l device info: catalog# c-tpn-5.0d-5-12-redo.(b)(4)event is still under investigation.

• Brand Name: REDO DOUBLE 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; p.o. box 489; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3981223
• MDR Text Key: 4888906
• Report Number: 1820334-2014-00311
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 06/24/2014

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: 10/31/2016
• Device Catalogue Number: C-TPNS-5.0D-65-12-RED
• Device Lot Number: 4510490
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2014
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2014
• 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