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)
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, two (2) days after the catheter had been in place, during visual inspection before treatment, it was observed that there was a crack (ruptured) and a leak at the venous (blue) luer adapter (end interface).Alcohol was the cleaning agent used on the device, and the device was tightened by hand.Iodine was the cleaning agent typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area.Excessive force was not used on the device.Tego was not utilized.Nothing unusual was observed on the device prior to use.There were no other products being utilized with the device.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The catheter was not repaired.The reported product was removed as a remedial action.There was no blood loss and blood transfusion was not required.There was no medical intervention/treatment done to the patient as a result of the event.There was no reported patient injury.
Additional Manufacturer Narrative
Correction: b5 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 that there was a crack on the luer adapter.It was reported that the luer adapter was leaking and cracked.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur from overtightening the adapter.Overtightening the luer adapter can apply excessive stress, leading to cracks or breaks in the material.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.
Event or Problem Description
According to the reporter, two (2) days after the catheter had been in place, during visual inspection before treatment, it was observed that there was a crack (ruptured) and a leak at the venous (blue) luer adapter (end interface).Alcohol was the cleaning agent used on the device, and the device was tightened by hand.Iodine was the cleaning agent typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area.Excessive force was not used on the device.Tego was not utilized.Nothing unusual was observed on the device prior to use.There were no other products being utilized with the device.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.No instrument was used to loosen or tighten the device.The catheter was not repaired.The reported product was removed as a remedial action.There was no blood loss and blood transfusion was not required.There was no medical intervention/treatment done to the patient as a result of the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the luer adapter was cracked.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: 21607425
• Report Number: 1282497-2025-00156
• Device Sequence Number: 9217282
• 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
• 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,Followup
• Report Date (Section B): 06/05/2025

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: 2320000105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/18/2025; 06/04/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/20/2025; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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 Sex: Unknown