MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR ACUTE DUAL LUMEN CATHETER FOR DIALYSIS; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 07/17/2019

Event Type  malfunction  

Event Description

Dual lumen straight hemodialysis catheter placed femorally by md.When he attempted to remove the guide wire he felt it was kinked and required some force to remove.Upon removal it was noted to have an area of shearing.

• Brand Name: MAHURKAR ACUTE DUAL LUMEN CATHETER FOR DIALYSIS
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8935057
• MDR Text Key: 155660445
• Report Number: 8935057
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Date Report to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1