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

Model Number 8888135191

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

According to the reporter, uremia patients needed to complete hemodialysis treatment regularly to remove excess water and toxins from the body.On (b)(6) 2024, the patient came to the hemodialysis room of our hospital for routine hemodialysis, which regularly removed excess water and toxins from the body.A nurse used a central venous catheter set to establish vascular access for a patient to perform hemodialysis.During the dialysis process, the nurse found fresh blood leaking from the outer dressing of the catheter.After multiple inspections, it was discovered that the catheter's silicone joint had a crack or tear, and hemodialysis could not continue.If dialysis was continued, air might enter the extracorporeal circulation line, causing coagulation, and might enter the blood circulation in the body, possibly causing air embolism.They were unable to perform normal dialysis, increasing the patient¿s risk of air embolism, and increasing the patient¿s financial burden.They immediately reported it to the doctor on duty.They immediately discharged the air in the pipe, returned blood, and took off the machine.It caused the patient's psychological tension, they patiently explained it to the patient, and replaced the catheter with a new one.Hemodialysis was resumed after the examination showed no problems.There was no reported patient outcome.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19166790
• MDR Text Key: 341686728
• Report Number: 1282497-2024-00061
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K192302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2024

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: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2226500190
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/23/2024
• Date Device Manufactured: 03/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male