MAUDE Adverse Event Report: COVIDIEN 11.5FR X 13.5CM MAHURKAR KIT; DIALYSIS CATHETER

Model Number 8813817005

Device Problems Air Leak (1008); Crack (1135)

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

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 reports that during a plasmapheresis session, air was noticed and lead to blood coagulation.After checking, a crack was noticed on the catheter.

Manufacturer Narrative

Submit date: 04/29/2016.The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are not non-conformances related to the reported issue for the reported lot.The product sample was returned for investigation.The sample consisted of one mahurkar catheter that presented signs of use (remains of blood).A visual inspection was performed and it was observed that the red adapter had a crack on the thread pitch area at 180 degrees and it had cavity #5.Additionally, the adapters did not present marks that could indicate the use of some instrument.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 it functioned as intended for an undetermined amount of time; therefore it can be concluded that the adapter was more likely damaged during use.The most probable root cause can occur during use.According to the instructions for use adapter over tightening may cause leaking.The reported condition is being addressed by a corrective and preventative action (capa).No additional actions are required.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.

• Brand Name: 11.5FR X 13.5CM MAHURKAR 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 street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5401344
• MDR Text Key: 37715492
• Report Number: 3009211636-2016-00061
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813817005
• Device Catalogue Number: 8813817005
• Device Lot Number: 1506100145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1