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

Model Number 8813793009

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/28/2016.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 reported that the guide wire did not slide properly into the interior of the catheter.Catheter presented pleated folds during insertion.There was no report of patient harm or medical intervention required.

• Brand Name: KIT 11.5FX19.5CM 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: 6129414
• MDR Text Key: 61233752
• Report Number: 3009211636-2016-00480
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 1602800122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1