MAUDE Adverse Event Report: COVIDIEN PALINDROME - P 19/36 VT KIT; DIALYSIS CATHETER

Model Number 8888145039P

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 5/4/2016.An investigation is currently under way; upon completion the results will be forwarded.Multiple attempts have been made to retrieve additional information.Upon receipt of additional pertinent information, a follow up report will be provided.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer states that dr.(b)(6) reported the palindrome catheter was defective.The catheter was removed and replaced on (b)(6) 2016.

Manufacturer Narrative

Submit date: 7/20/16.A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The sample consisted of pull apart sheath.This component was returned inside a generic plastic bag and showed signs of use (remains of blood).Visual inspection was performed and it observed that the pull apart was separated on two parts.Additionally, the two parts of the tubing were detached of the tubing pinch.Process failure mode and effect analysis was reviewed in order to identify potential causes associated with this event.In addition, a brainstorming session was performed with the purpose to identify additional potential causes.As a result, in the following fishbone diagram are the potential causes.The reported defect was confirmed, the sample was returned for evaluation.Based on previous information the most probable root cause for this defect is defective material from the supplier.During visual inspection it was found that the pull apart sheath show signs of use and was separated on two parts.Additionally, the two parts of the tubing were detached of the tubing pinch due to the tube not being positioned correctly during molding.Since this complaint was related to the supplier, it is classified as manufacturing related, this triggers an analysis to determine the need for action.A formal corrective and preventative action has been opened for this issue.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing activities.In addition, as a preventive action for manufacturing site operations, a monthly complaints report is sent to focus factory personnel, summarizing the latest events reported by the customer.

• Brand Name: PALINDROME - P 19/36 VT KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: matthew amaral ; 15 hampshire st.; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5630402
• MDR Text Key: 44899810
• Report Number: 3009211636-2016-00193
• Device Sequence Number: 1
• Product Code: MSD
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145039P
• Device Catalogue Number: 8888145039P
• Device Lot Number: 1533200065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1