MAUDE Adverse Event Report: COVIDIEN MAHURKAR 13.5FRX19.5CM SE KIT; DIALYSIS CATHETER

Model Number 8888135191

Device Problems Air Leak (1008); Hole In Material (1293)

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

Event Date 03/25/2015

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that 2 hours after the start of the dialysis, the alarm rang because of air bubbles.The adapter of the device, vein side (blue part to the machine) melt on about 5mm, and made a hole in the extension tubing causing the air bubbles.The catheter was removed and another device with same lot# was used to complete the procedure successfully.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

The complaint sample was not returned to the manufacturing site for review.The manufacturing lot number associated with this complaint was released on 09/06/2013.The device history record (dhr) review indicated that there was no quality issues associated with this reported condition.All dhrs are reviewed for accuracy prior to product release.Since the sample was not returned, there is not enough evidence to determine what could have caused this event.With the available information it is not possible to confirm a root cause for this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are no non-conformances related to the reported issue for the involved lot.There were no changes identified that may impact the product/process related to the reported condition during a period of six months prior to the manufacturing date.A sample was received for investigation.The sample consisted of one mahurkar catheter which presented signs of use (dirt and remaining blood).Visual inspection was performed and a hole was found on the venous extension, near the blue adapter.The sample returned was submitted to an underwater test and bubbles were detected.The bubbles were coming out from the venous extension.As per the instructions for use (ifu), it is necessary to perform a visual inspection before using the device.Do not use the catheter if it is crushed, cracked, cut or otherwise damaged.Clamping the catheter repeatedly in the same spot could weaken the tubing.Exercise caution when using sharp instruments near the catheter.The catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, or cuts which could impair its performance.The sample returned presented a hole on venous extension, below blue adapter.The dwell time was 2 hours and after that started the process of dialysis.The issue was not identified prior to the insertion and the device functioned as intended.Additionally, manufacturing performs 100% visual inspection on catheter extensions and 100% pressure (leak) testing.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.The most probable root cause is that the product was damaged during use due to the inappropriate use of sharp objects, repeated clamping or other similar damage.The evidence provided is enough to discard the manufacturing process as a potential cause.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 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: MAHURKAR 13.5FRX19.5CM SE 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4651084
• MDR Text Key: 5758629
• Report Number: 3009211636-2015-00184
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 323435X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1