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

Model Number	8888135241
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
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 undergoing bedside dialysis in the icu.The doctor connected the hemodialysis catheter normally.Half an hour later, the nurse discovered that the hemodialysis catheter had slipped off.There was nothing unusual observed on the device prior to use.Flushing was done prior to use and with normal results.There was no leak, and tego was not utilized.There was no luer adapter issue.Iodine was the cleaning agent used on the device.There were no other products being utilized with the device.No excessive force was used on the device.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The stitches hold, the ring of the suture wing was broken, and the separation from the retaining ring (wing) failed.As a remedial action done, the doctor was contacted promptly to remove it and replace the hemodialysis catheter.This was also the intervention/treatment performed.The catheter has been in place for 1 hour.Reintubation was the medical intervention.The treatment continued after the catheter was replaced.There was 2 ml of blood loss, and blood transfusion was not required due to the event.There was no reported patient injury.
Event or Problem Description
According to the reporter, the patient was undergoing bedside dialysis in the icu.The doctor connected the hemodialysis catheter normally.Half an hour later, the nurse discovered that the hemodialysis catheter had slipped off.There was nothing unusual observed on the device prior to use.Flushing was done prior to use and with normal results.There was no leak, and tego was not utilized.There was no luer adapter issue.Iodine was the cleaning agent used on the device.There were no other products being utilized with the device.No excessive force was used on the device.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The stitches hold, the ring of the suture wing was broken, and the separation from the retaining ring (wing) failed.As a remedial action done, the doctor was contacted promptly to remove it and replace the hemodialysis catheter.This was also the intervention/treatment performed.The catheter has been in place for 1 hour.Reintubation was the medical intervention.The treatment continued and was completed after the catheter was replaced.There was 2ml of blood loss, and blood transfusion was not required due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, e1(first name, last name), e3, 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.

• 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: 21065007
• Report Number: 1282497-2025-00006
• Device Sequence Number: 12861742
• Product Code: MPB
• UDI-Device Identifier: 10884521006539
• UDI-Public: 10884521006539
• 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: 8888135241
• Device Catalogue Number: 8888135241
• Device Lot Number: 2327000134
• 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: 12/24/2024
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 11/17/2023
• 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: 69 YR
• Patient Sex: Male