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

Model Number 8888135241

Device Problem Break (1069)

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

Event Date 03/06/2024

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, after the catheter was inserted, blood leakage was found at the end of the catheter.It was noted that there were holes or cracks in the end of the catheter.There was no luer adapter issue.There was nothing unusual observe on the device prior to use and there were no other defects/damages found on the product aside from holes or cracks.There were no other products being utilized with the device.There was no excessive force used on the device.Tego was not utilized.Normal saline was utilized to clean the catheter in its entirety.There was no cleaning agents included on the would dressing.Cleaning agent allowed to dry thoroughly prior to dressing the area and applying ointment to the area.Cleaning agents not mixed.The patient was not responsible for any type of catheter maintenance.Cleaning agents not switched over the life of the catheter.Sepsiderm was not used to the site to clean the catheter.There was no protocol change for cleaning agents used recently.Patient was not using any type of cleaning agent or antibiotic on the catheter.As a remedial action, the reported product was replaced with a new set of catheter with the same product id and lot at the same day of the event.The patient was transferred to icu (intensive care unit) ward after replacing the product.There was no blood transfusion required.There was no intervention/treatment required as a result of the leaking.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: 19093865
• MDR Text Key: 340687678
• Report Number: 1282497-2024-00036
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006539
• UDI-Public: 10884521006539
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

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: 8888135241
• Device Catalogue Number: 8888135241
• Device Lot Number: 2324000153
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/11/2024
• Date Device Manufactured: 09/27/2023
• 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