MAUDE Adverse Event Report: COVIDIEN KIT 11.5FX13.5 CE MAHURKAR; DIALYSIS CATHETER

Model Number 8813817009

Device Problems Partial Blockage (1065); Failure to Prime (1492)

Patient Problem No Information (3190)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/26/2016.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 starting the dialysis session, flushing of the catheter was done, one lumen was fine and in the other lumen there was a block, we were unable to flush the lumen.

Manufacturer Narrative

Per additional information received 8/29/16, the arterial lumen was blocked and the blockage was not cleared.The catheter was replaced with a new one.The catheter was originally implanted on (b)(6) 2016 and a new catheter was implanted the same day.There was no medical intervention or patient harm.

Manufacturer Narrative

Submit date: 12-5-16.The manufacturing lot number associated with this complaint was reviewed and no failures related to the reported condition were identified.The product sample was returned to the manufacturing site for evaluation.Visual inspection was performed and the catheter did not reveal any visual issues.In order to confirm the issue reported, a guide wire of the sample was passed through both extensions; as result the guide wire passed easily through the venous extension, however the guide wire did not pass through the hub in the arterial extension.Additionally it was observed that the hub was partially obstructed.From the sample evaluation it was confirmed that obstruction of the hub channel is due to an excess of dimethylacetamide during operation.Assembly between the tube and the hub is a manual operation and solvent bonding technique can occlude the hub channels.The evidence provided is enough to relate this event to manufacturing operations.A formal corrective and preventative action investigation was opened to address this issue.No further actions are required.In-process controls are in place to prevent nonconforming product from leaving the manufacturing plant.This complaint will be used for tracking and trending purposes.

• Brand Name: KIT 11.5FX13.5 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 st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5906126
• MDR Text Key: 54088721
• Report Number: 3009211636-2016-00359
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1535000134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1