MAUDE Adverse Event Report: COVIDIEN 19/36 PALINDROME P KIT X5; DIALYSIS CATHETER

Model Number 8888145014P

Device Problem Hole In Material (1293)

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

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer alleges that a palindrome catheter inserted at this hospital has a hole in it.

Manufacturer Narrative

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 product sample was returned for investigation, it consisted in a palindrome catheter, product id 8888145014p, that showed signs of used (blood residues).Functional test was performed in order to confirm the defect reported by the customer, after the test the catheter showed a leakage in the venous extension.Visual inspection of the sample revealed an irregular pin hole in the silicone tubing.Sample was received damaged after being manipulated by the customer, this manipulation could be associated to the damaged found in the extension; therefore it can be concluded that this defect could be related to the use of sharp objects or rough edges after or during catheter insertion.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time.Moreover, 100% devices are inspected for leaks or cuts in the extensions; therefore the most probable root cause can be considered as misuse; this defect was more likely damaged during use caused due to the inappropriate use of sharp objects, repeated clamping or other similar damage.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection, leak testing and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% leak testing at the final stage of production, which would identify this issue in the catheter assembly.No additional actions are required.This complaint will be used for tracking and trending purposes.

• Brand Name: 19/36 PALINDROME P KIT X5
• 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: thom mcnamara ; 15 hampshire st.; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5563531
• MDR Text Key: 42895236
• Report Number: 3009211636-2016-00153
• 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: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145014P
• Device Catalogue Number: 8888145014P
• Device Lot Number: 1521000157
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1