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

Model Number	8888135191
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the patient was admitted to the icu (intensive care unit) on (b)(6) and underwent hemofiltration using a catheter kit.On (b)(6), during the examination before hemofiltration, the doctor found a 0.2-0.3 mm (millimeter) crack on the brown catheter tip, and it could not be used.The patient needed a second intubation; the catheter was replaced with a new catheter kit, and the material library was notified as a preliminary action, which caused the patient to suffer an additional intubation injury (the original damaged catheter was needed to be removed, and a new catheter was needed to be implanted) and prolonged the day's hemofiltration treatment time.There was nothing unusual observed on the device prior to use.Flushing was done prior to use.There were no other defects/damages found on the product.There was no cleaning agent used on the device.The adapter was tightened by hand.There were no other products being utilized with the device.Extubation was needed as the medical intervention/treatment required as a result of the event.The event did not lead to blood vessel damage to the patient.The treatment was completed.There was no blood loss, and blood transfusion was not required.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.
Event or Problem Description
According to the reporter, the patient was admitted to the icu (intensive care unit) on (b)(6) and underwent hemofiltration using a catheter kit.On (b)(6), during the examination before hemofiltration, the doctor found a 0.2-0.3 mm (millimeter) crack on the brown catheter tip, and it could not be used.There was nothing unusual observed on the device prior to use.Flushing was done prior to use, and no abnormality was found.There were no other defects/damages found on the product.There was no cleaning agent used on the device.The adapter was tightened by hand.There were no other products being utilized with the device.The patient suffered an additional intubation injury, which meant the original damaged catheter needed to be removed/extubated as the medical intervention/treatment as a result of the event, and the patient needed a second intubation; a new catheter was needed to be implanted on the same day.The material library was notified as a preliminary action, which caused the patient to be delayed and prolonged the day's hemofiltration treatment time, and the treatment was completed.There was no blood loss, and blood transfusion was not required.The event did not lead to blood vessel damage to the patient.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, 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: 21065042
• Report Number: 1282497-2025-00007
• Device Sequence Number: 14305222
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2308000086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 03/26/2023
• 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: 70 YR
• Patient Sex: Female