MAUDE Adverse Event Report: COVIDIEN PERMCATH 40CM; DIALYSIS CATHETER

Model Number 8817749001

Device Problems Fluid/Blood Leak (1250); Split (2537)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/30/2016.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 it was found there was a leak 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

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The product sample was returned for investigation, it consisted in a mahurkar catheter 11.5fr x 13.5cm that is different to product reported, a marked guide wire, an introducer needle, a dilator 10fr, a dilator 12fr and an original polybag with its respective label.The venous extension showed signs of use and the other components did not show signs of use.Visual inspection was performed and it revealed one cut in the venous extension and the blue adapter was detached from the extension and was not returned.The red adapter was not well placed in the extension.The extensions did not present others marks.Additionally, the clamps were reviewed and as a result no issues or irregularities were found.In the evaluation of the sample the lot number was found.An ishikawa diagram was used to determine the potential causes for this event.Manufacturing performs 100% pressure leak testing.The issue was not identified prior to use 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.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 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: PERMCATH 40CM
• 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: 5536307
• MDR Text Key: 41769933
• Report Number: 3009211636-2016-00144
• 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: 03/23/2016

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: 8817749001
• Device Catalogue Number: 8817749001
• Device Lot Number: 230606X
• 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