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

Model Number 8888135191

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/25/2016.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 when placing the catheter into the patient, the guide wire did not come out, the guide was detached from the system.They do not know if there is some part of the device inside the patient.

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 dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation, however four photos were provided by the customer.Visual evaluation of these photos was performed; the first three pictures showed a guide wire inside a generic plastic bag, in these photos it could be observed that the guide wire was stretched and bent on different points of its surface, the last photo was observed with an original label of the (b)(6) product; this image was not clear enough, the description and lot number of the product could not be identified.With the available evidence, it was not possible to determine if the guide wire presented a defective condition that may be related to the reported condition.According to the lot history record review, the referred lot does not reveal any deviation of the current procedure that might have contributed to the defective reported condition.The guide wire is covered by a plastic component which has the purpose of assuring the integrity of the stainless steel.This component has defined characteristics as part of its design which makes it flexible for gentle manipulation during use.The photo evaluation revealed that the guide wire was stretched and it was heavily manipulated, which implies that there were attempts to introduce it.According to the event description the defect occurred after customer manipulation during the initial insertion, the defect was not identified and the guide wire functioned as intended the moment when it was introduced in the patient.There is no evidence to link this failure with manufacturing activities.Based on the available information the guide wire was damaged during the catheter insertion and the most possible cause for this issue is related to excessive force during the insertion.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for (b)(4), 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: 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5903547
• MDR Text Key: 54055962
• Report Number: 3009211636-2016-00358
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• 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: 1602700231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1