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

Model Number 8888135191

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

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 a leak was found with the connector of the catheter during dialysis treatment for the patient.There was a cleft (split) on the venous side.The physician replaced it with a new catheter.There was no patient injury reported.

Manufacturer Narrative

Submit date: 07/18/2016.The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are no nonconformance records related to the reported issue for the involved lot.No changes were identified that may impact the product or process related to the reported condition during a period of six months prior to the manufacturing date.The product sample was returned for investigation.It consisted of an incomplete kit that was received inside a plastic bag.The catheter presented signs of use.Visual inspection was performed and it revealed one cut in the venous extension in the area where the adapter meets the silicone extension.The cut looked irregular.The extensions did not present others marks.Additionally, the clamps were reviewed and as result no issues were identified.An ishikawa diagram was used to determine the potential causes for this event.Manufacturing performs 100% pressure (leak) test.The reported condition was not identified prior to insertion and functioned as intended for the reported amount of time.As per the instructions for use (ifu), the customer has to perform a visual inspection before using the device.The sample was received damaged after being in use; this is evidence that the catheter was manipulated.This manipulation could be associated to the damaged found in the extension.The reported condition has been confirmed.The most probable root cause can be considered as misuse.This product was more likely damaged during use caused due to the inappropriate use of sharp objects, repeated clamping or other similar damage.A corrective and preventative action (capa) and health hazard evaluation (hhe) were opened to address this failure mode in this product family.No complaint triggers or trends were identified.Further actions are not 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, 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: 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 manuf. solutions sa; edificio 820 calle#2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire st.; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5535913
• MDR Text Key: 41484760
• Report Number: 3009211636-2016-00141
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• 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: 313641X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1