MAUDE Adverse Event Report: COVIDIEN COVIDIEN; MAHUKAR CATHETER WIRE

Model Number

Device Problem Break (1069)

Patient Problem Neck Pain (2433)

Event Date 11/09/2020

Event Type  Injury  

Event Description

Patient needed a central line placed for emergent dialysis.Md attempted to place a central line in the right ij.During attempt, the tip of a guide wire from a marhukar dialysis catheter set broke off and was left inside the pt.A second line was successfully placed in the patient's right groin and the patient was able to undergo dialysis as planned.Cardio vascular surgery was consulted.Ct of the neck without contrast revealed the wire not to be in the vessel completely; therefore, it was not urgent to remove the wire at that time.

• Brand Name: COVIDIEN
• Type of Device: MAHUKAR CATHETER WIRE
• Manufacturer (Section D): COVIDIEN; columbia heights MN 55421
• MDR Report Key: 11245345
• MDR Text Key: 229367354
• Report Number: 11245345
• Device Sequence Number: 1
• Product Code: MPB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional

Device Model Number

Device Catalogue Number

Device Lot Number

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2020
• Distributor Facility Aware Date: 11/09/2020
• Event Location: Other
• Date Report to Manufacturer: 12/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 DA
• Patient Weight: 79