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

Model Number	8888222220
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 - concomitant product: 8888222220 12fr 20cm elite curv dl kit, 8888222220, lot: 2127300074 8888222220 12fr 20cm elite curv dl kit, 8888222220, lot: 2127300074.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, after inserting the needle into the vein and inserting the guide wire, the needle got stuck in the guide wire and was not removed.This was observed in both of the two (2) kits.There was no leak.There was no luer adapter issue.The insertion site was not treated prior to product placement.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, e1(first name, last name, street 1, street 2, phone number), e2, e3, g3, h1, h6 new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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, after inserting the needle into the vein and inserting the guide wire, the needle got stuck in the guide wire and was not removed.Both two kits had the same issue and were used on the same patient.Both kits were observed during the same event.There was no leak.There was no luer adapter issue.The insertion site was not treated prior to product placement.The guidewire was provided with the kit being used.The guide wire was neither frayed, coiled, nor unraveled.The puncture needle was provided with the kit being used.Flushing was done prior to use, but the result was not provided.The guide wire was removed at the same time as the needle, and it remained intact when removed.The kit was replaced.The procedure was completed.There was blood loss, but no information on the amount of blood lost was provided, and a blood transfusion was required.Medical intervention/treatment was required as a result of the event.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3.Evaluation summary: mozarc medical conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted a guidewire that had been inserted into a puncture needle, with visible signs of use.When removing the guidewire from the puncture needle, abnormal resistance was felt, and biological tissue was spotted.It was reported that the guidewire could not be withdrawn.The reported issue was confirmed.The most likely cause was not traced to the device but rather to biological obstruction.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all mozarc medical 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 ELITE
• 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: jon cornell ; 15 hampshire street; mansfield, MA 02048 ; 8772111850
• MDR Report Key: 23796729
• Report Number: 1282497-2025-00659
• Device Sequence Number: 10453371
• Product Code: MPB
• UDI-Device Identifier: 10884521125841
• UDI-Public: (01)10884521125841(17)270309(10)2127300074
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K120674
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888222220
• Device Catalogue Number: 8888222220
• Device Lot Number: 2127300074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 03/17/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/19/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NOTES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown