MAUDE Adverse Event Report: COVIDIEN KIT 11.5FX19.5 CE MAHURKAR; DIALYSIS CATHETER

Model Number 8813793013

Device Problems Partial Blockage (1065); Device Damaged Prior to Use (2284)

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

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/02/2016.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 before use in the patient, the nephrologist observed that the catheter was obtruded (pushed forward) in the lumen at the height of the fork (bifurcate), the guide wire does not pass into the lumen.There is a blockage in the lumen.The physician decided not to use the product.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was received for evaluation.A visual inspection was performed and the catheter did not reveal any visual issues.A guide wire was passed through both extensions.The guide wire passed through the arterial extension; however, the guide wire did not pass through the hub of the venous extension.The hub was obstructed and the orifice looks smaller.A resin was found on the venous lumen.The issue was caused during the bond tube and hub process step, due to an excess of glue used in this operation.This issue was not captured during the inspection process.A formal corrective and preventative action was opened for this reported issue.Additional actions are not required at this time.It must be noted that in-process controls as visual inspection according to test procedure (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 non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: KIT 11.5FX19.5 CE MAHURKAR
• 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 02480 ; 5084524151
• MDR Report Key: 5924154
• MDR Text Key: 54502605
• Report Number: 3009211636-2016-00371
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813793013
• Device Catalogue Number: 8813793013
• Device Lot Number: 1530100179
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1