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

Model Number	8888145001
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the patient had chronic kidney disease and was regularly undergoing hemodialysis at the hospital.On (b)(6) 2025, a catheter kit was implanted for vascular access and blood withdrawal to facilitate hemodialysis.The first use of this catheter occurred on (b)(6) 2025, for a session that lasted 1 hour and 30 minutes.During this procedure, blood flow through the catheter was poor, and the machine frequently alarmed, preventing continuation of the dialysis, which was terminated early.There was nothing unusual observed on the device prior to use.Flushing was done and with normal results.There was no leak, and tego was not utilized.There was no luer adapter issue.The insertion site was not treated prior to product placement.There were no other products being utilized with the device.There was no excessive force used on the device.The patient's medication regimen involved an initial dose of 10 mg of heparin administered via arterial injection, followed by continuous arterial infusion at a rate of 3.5 mg/hour.The total dosage administered over the course of treatment was 10.5 mg, as the intervention/treatment required as a result of the event.Aside from the reported issue, there were no other visible defects/damages found on the product at the time of the event.The dialysis was prematurely terminated, shortening the session duration, and as a remedial action, an autogenous arteriovenous fistula was planned as an alternative vascular access.The treatment proceeded and was completed after the remedial action was done.There was no blood loss, and no blood transfusion was required due to the event.There was no reported patient injury.
Additional 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22515580
• Report Number: 1282497-2025-00508
• Device Sequence Number: 8011961
• Product Code: MSD
• UDI-Device Identifier: 10884521014084
• UDI-Public: (01)10884521014084(17)281028(10)2318600151
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: 8888145001
• Device Catalogue Number: 8888145001
• Device Lot Number: 2318600151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Unknown