MAUDE Adverse Event Report: COVIDIEN MAXID 19/38 KIT W/OUT SIDEHOL; DIALYSIS CATHETER

Model Number 8888145001

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/20/2013

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a dialysis catheter.The customer states that the catheter tube was unable to draw blood or phlebotomize.The physician replaced the catheter to give dialysis treatment.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: MAXID 19/38 KIT W/OUT SIDEHOL
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer (Section G): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer Contact: lawrence rock ; 15 hampshire st.; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 3703943
• MDR Text Key: 16802748
• Report Number: 1317749-2014-00089
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/24/2014

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: 8888145001
• Device Catalogue Number: 8888145001
• Device Lot Number: 135722X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/18/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1