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

Model Number 8888145039P

Device Problem Hole In Material (1293)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/07/2015.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer states that a surgeon found a hole near the catheter tip.The issue was noticed while inserting in the patient.The catheter was pulled and replaced as a result.The catheter was inserted and pulled on (b)(6) 2015.There was no medical intervention required and there was no harm to the patient.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was release accomplishing all quality standards.A palindrome catheter was received inside a generic plastic bag.The catheter presented signs of use (rests of blood).In order to confirm the defect reported, sample was submitted to underwater test and bubbles were detected.The lumen related to the arterial extension did not show bubbles during the test.A pinhole was found on the venous extension.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that the product was manufactured according to specifications and the device functioned as intended for the reported amount of time.The most probable root cause can be considered as misuse; this defect was more likely damaged during use caused due to the improper use of sharp objects, repeated clamping or other similar damage.The evidence provided is enough to discard the manufacturing process as a potential cause.A qseas evaluation took place to assess this exceeded risk threshold, no further investigation activities or corrective actions were required and a hhe evaluation was opened.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 and a 100% visual inspection during 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: 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 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5135630
• MDR Text Key: 28146950
• Report Number: 3009211636-2015-00403
• 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,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/30/2015

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: 8888145039P
• Device Catalogue Number: 8888145039P
• Device Lot Number: 1500600149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1