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

Model Number	8888135241
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during use, there was a rupture in the catheter extension tube, and oozing blood was found.It was also stated that there was a leak at the bifurcate.There was nothing unusual observed on the device prior to use.Besides the reported issue, there were no other visible defects or damages found on the product at the time of the event.Flushing was done with no abnormalities.The catheter was not repaired.There was no luer adapter issue, and tego was not utilized.Iodophor was the cleaning agent used on the device.The insertion site was treated prior to product placement.No excessive force was used on the device.An extracorporeal circulation line was the other product utilized with the device.The catheter was replaced as a remedial action.A small amount of blood loss occurred, and blood transfusion was not required due to the event.No treatment was required as a result of 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted one catheter, with a pin-hole leak.There appeared to be no abnormalities with the device.It was reported that there was a leak on the extension tube and the bifurcate was cracked.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur by the catheter coming into contact with a sharp instrument during use.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one catheter, with a pin-hole leak.There appeared to be no abnormalities with the device.It was reported that there was a leak on the extension tube and the bifurcate was cracked.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur by the catheter coming into contact with a sharp instrument during use.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 21606406
• Report Number: 1282497-2025-00150
• Device Sequence Number: 9275374
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

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: 2324000153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 05/08/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/18/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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: 46 YR
• Patient Sex: Unknown