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

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

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 meropenem 3 times/day, cymevene 2 times/day and ciprofloxacin 2cc/min during 1 h.After 14 days with no problem the small lumen ruptured in the extension 4-5 cm 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 greater than 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 the rupture.The distal end of the catheter was still in place, it was surgically retrieved and there was insertion of a new cvc.According to the initial reporter, the patient did not experience any adverse effects due to this occurence.

Manufacturer Narrative

(b)(4).As of (b)(4) 2014, no product has been returned to assist in the investigation.A review of complaint history, instructions for use, and quality control were conducted during the investigation.There is no evidence to suggest that the product was not manufactured to specifications.Quality control confirms the overall catheter surface is clean and free of damage or excessive imperfections.This product is shipped with instructions for use which states under warnings: "if lumen flow is impeded, do not force injection or withdrawal of fluids." / precautions: "silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture." we are unable to determine with certainty as to why this failure mode occured.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Quality engineering assesment was used to assess the risk of this complaint.A capa was previously closed regarding this failure mode.

• 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; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3981135
• MDR Text Key: 4886297
• Report Number: 1820334-2014-00324
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-TPNS-5.0D-65-12 REDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2014
• Event Location: Hospital
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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