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

Model Number	8888145001
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter, the patient was admitted to the nephrology ward of the hospital on (b)(6) 2025, at 15:24:09, due to stage 5 chronic kidney disease.Following admission, a chronic catheter was placed for hemodialysis, and the catheter was regularly replaced during the hospital stay.On the day of the event at 16:50:00, the patient's family reported the sudden appearance of minor blood extravasation at the venous end of the dialysis catheter without any apparent trigger.The nurse inspected the catheter and found no obvious cracks; after sealing and dressing the catheter, no further bleeding was observed.However, early the next morning, bleeding recurred from the catheter.Examination revealed a pinhole-like crack in the catheter wall with bleeding.The upper segment of the catheter was clamped to control bleeding.On (b)(6), the catheter segment was replaced, and no further bleeding was observed.Nothing unusual was observed on the device prior to use.There were no other products being utilized with the device.There was no excessive force use on the device.Tego was not utilized.There was no luer adapter issue.The insertion site was treated prior to product placement.Flushing was done and the result was normal.The cleaning agent allowed to dry thoroughly prior to applying ointment to the area.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.As a remedial action and intervention, the catheter was repaired by replacing the catheter segment, and no further bleeding was observed.The procedure was completed after the remedial action performed.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Correction: b5 additional information: g3 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.
Event or Problem Description
According to the reporter, the patient was admitted to the nephrology ward of the hospital on (b)(6) 2025, at 15:24:09, due to stage 5 chronic kidney disease.Following admission, a chronic catheter was placed for hemodialysis, and the catheter was regularly replaced during the hospital stay.On the day of the event at 16:50:00, the patient's family reported the sudden appearance of minor blood extravasation at the venous end of the dialysis catheter without any apparent trigger.The nurse inspected the catheter and found no obvious cracks; after sealing and dressing the catheter, no further bleeding was observed.Nothing unusual was observed on the device prior to use.There were no other products being utilized with the device.There was no excessive force use on the device.Tego was not utilized.There was no luer adapter issue.The insertion site was treated prior to product placement.Flushing was done and the result was normal.The cleaning agent allowed to dry thoroughly prior to applying ointment to the area.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.As a remedial action and intervention, the catheter was repaired by replacing the catheter segment, and no further bleeding was observed.The procedure was complet ed after the remedial action performed.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.

• 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: 22494566
• Report Number: 1282497-2025-00502
• Device Sequence Number: 4175067
• Product Code: MSD
• UDI-Device Identifier: 10884521014084
• UDI-Public: (01)10884521014084(17)281224(10)2330300072
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 2330300072
• 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: 06/29/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 07/16/2025
• Date Device Manufactured: 01/25/2024
• 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: 74 YR
• Patient Sex: Unknown