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

Model Number	8888145252
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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, during procedure, the catheter had flow issue, blood was not coming and was blocked.The catheter was not repaired.There was no leak.Saline water was the cleaning agent used on the device.Tego was not utilized.There was no luer adapter issue.The insertion site was treated prior product placement.The product was replaced with the same lot.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.Visual inspection noted one catheter, sealed in a package with visible signs of use.There appeared to be no abnormalities with the device.It was reported that there was an insufficient flow issue.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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, during the procedure, the catheter venous line had a flow issue; blood was not coming and was blocked.The catheter was not repaired.There was no leak.Saline water was the cleaning agent used on the device.Tego was not utilized.There was no luer adapter issue.The left jugular side insertion site was treated prior product placement.The catheter was in place for the 40-minute duration of the procedure.There was no blood return prior to the syringe flush.It was hard to flush the line with the syringe, so the doctor had not confirmed whether the flushing was done.No anticoagulation was used.No other defects/damages were found on the product.No other products were being utilized with the device.Nothing unusual was observed on the device prior to use.The reverse flow was not successful.The product was replaced with the same lot and product id (identifier) on the same day; this resolved the issue, and the treatment was completed.There was no blood loss.Blood transfusion was not required.No medical intervention/treatment was required as a result of the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, d6a, d6b, e1(facility name, street 1, postal code), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted one catheter with visible signs of use.Before flushing the device, it was noted that both extension lines were clamped shut.After unclamping the extension lines, the inner tubing of each line appeared to be closed.This blocked any water from being flushed through the extension lines.By applying force, the lines were restored and could be flushed.It was reported that there was an insufficient flow issue.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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, 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: 21035578
• Report Number: 1282497-2024-20060
• Device Sequence Number: 8433325
• Product Code: MSD
• UDI-Device Identifier: 10884521014244
• UDI-Public: 10884521014244
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 02/26/2025

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: 8888145252
• Device Catalogue Number: 8888145252
• Device Lot Number: 2405800233
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 02/24/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/20/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2024
• 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: Male