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	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, there was a crack in the arterial segment port (red luer adapter).The catheter was repaired.There was leak at the luer adapter.There was no instrument used to loosen or tighten the device.Iodine disinfection was the cleaning agent used the device.Tego was utilized.The insertion site was not treated with prior to product placement.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, during dialysis treatment, there was a crack in the arterial segment port (red luer adapter).There was nothing unusual observe on the device prior to use.Flushing was done prior to use.The catheter was implanted for more than two months.There was leak at the arterial end of the luer adapter.There was no instrument used to loosen or tighten the device.Iodine disinfection was the cleaning agent used the device.The cleaning agent were allowed to dry thoroughly prior to applying ointment to the area.Tego was utilized.The insertion site was not treated with prior to product placement.There was no intervention/treatment required as a result of the event.As a remedial action performed, the catheter was repaired by replacing the cracked port with temporary catheter using repair kit.There was no blood loss and blood transfusion required due to he event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that there was a cut in the extension tube where it met the arterial luer adapter.The placement of the cut suggests it was created by clamping the tubing too close to the luer adapter.Clamping the extension tube close to the luer adapter can cause excess stress on the extension tubing which can lead to breaks/leaks in the tubing where it connects to the luer adapter.It was reported that the luer adapter was leaking, cracked or broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: clamping repeatedly on the same spot could weaken the tubing and clamping near the adapter and hub should be avoided.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: 20515911
• Report Number: 1282497-2024-00454
• Device Sequence Number: 7110507
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 2226500195
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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 Sex: Prefer Not To Disclose