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

Model Number 8888135162

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

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 Description

According to the reporter, during saline pre-fill, there was a leak at the extension tube (arterial side) and bifurcation connection.Nothing unusual was observed on the device prior to use.Flushing/priming was done prior to use and no problem was found.Tego was not utilized and there was no luer adapter problem.Iodophor was used as the cleaning agent on the device.Alcohol-free sanitized iodophor was not utilized to clean the adapters and no ointment was applied.The insertion site treated with prior to product placement.Catheter was not repaired.There were no other products being utilized with the device.No excessive force applied on the device and no instrument was used to loosen or tighten the device.The catheter was explanted and replaced with a product from another manufacture as a remedial action to resolve the issue.There was a 50 milliliter (ml) blood loss and blood transfusion was not required.There was no intervention/treatment provided to the patient.There was no reported patient injury.

• Brand Name: MAHURKAR
• Type of Device: 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: 19099663
• MDR Text Key: 340804350
• Report Number: 1282497-2024-00039
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006379
• UDI-Public: 10884521006379
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K192302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 8888135162
• Device Catalogue Number: 8888135162
• Device Lot Number: 2234800115
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/12/2024
• Date Device Manufactured: 03/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male