MAUDE Adverse Event Report: COVIDIEN MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888211424

Device Problem Flushing Problem (1252)

Patient Problem Failure of Implant (1924)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

The 13.5fr 24cm mahurkar vascath opened up on sterile table for vascath placement.Unable to flush red port of vascath.Catheter removed and another one was used for pt.

• Brand Name: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 16598336
• MDR Text Key: 311960570
• Report Number: MW5115939
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/21/2023

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 Expiration Date: 02/20/2024
• Device Model Number: 8888211424
• Device Lot Number: 2226500218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1