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

Model Number	8888135241
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the puncture, the guidewire got stuck in the needle and cannot be moved.There are three consecutive catheter changes.The same issue was observed during all three consecutive catheter changes.All three catheter changes occurred during the same event.All three catheters were reported to have been in the same patient.There was nothing unusual to observe on the device prior to use.There was no excessive force used on the device.There were no other products being utilized with the device.Flushing was done, and the result was normal.The catheter was not repaired.There was no leak.There was no cleaning agent used on the device.Tego was not utilized.There was no luer adapter issue.The insertion site was not treated prior to product placement.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The guidewire provided with the kit was being used.The guidewire was intact upon removal.The guidewire was stuck in the needle and was removed from the patient together with the needle.As a remedial action, the reported product was replaced with the new catheter, and the surgery was completed.There was no intervention/treatment required as a result of the event.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
D10-concomitant product: 8888135241 13.5fr 24cm mahka q+ se kit- lot #: 2327000135 8888135241 13.5fr 24cm mahka q+ se kit- lot #: 2327000135 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
Correction: b5.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 the puncture, the guidewire became stuck in the needle and could not be moved.This issue occurred during three consecutive catheter changes, all of which took place during the same procedure and involved the same patient.There were no abnormalities observed on the devices prior to use.No excessive force was applied, and no other products were utilized with the device.Flushing was performed and with a normal results.The catheters were not repaired, and no leaks were noted.No cleaningagents were used, tego were not utilized, and there were no issues with the luer adapter.The insertion site was not treated prior to product placement.Aside from the reported issue, no visible defects or damage were observed on the products at the time of the event.The guidewire remained intact upon removal.The guidewire, which was stuck in the needle, was removed from the patient along with the needle.As a remedial action, the reported product was replaced with a new catheter, and the procedure was successfully completed.There was no intervention/treatment required as a result of the event.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.

• 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: 22066543
• Report Number: 1282497-2025-00342
• Device Sequence Number: 20965051
• 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
• 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
• Report Date (Section B): 07/31/2025

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: 2327000135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/31/2025
• Date Device Manufactured: 11/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 69 YR
• Patient Sex: Unknown