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

Model Number 8888135191

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/18/2024

Event Type  malfunction  

Event Description

According to the reporter, the doctor performed perfusion treatment at the bedside.After successfully placing the tube in the neck, found blood oozing was noted.Upon inspection, there was a break in the tube at the venous end extension tube.The clamps moved to a new location after treatment.There were no other defects/damages found on the product aside from the reported issue.There were no other products being utilized with the device.There was no excessive force used on the device.Flushing was done with normal result.The issue was reported to the doctor immediately and replaced the tube with the same product id and lot at the same day of the event as remedial action.There was no blood loss, and no blood transfusion was required.There was no intervention/treatment required as a result of the event.There was no reported patient injury.

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, the doctor performed perfusion treatment at the bedside.After successfully placing the tube in the neck, found blood oozing was noted.Upon inspection, there was a break in the tube at the venous end extension tube.The clamps moved to a new location after treatment.No abnormalities were observed on the device prior to use.There were no other defects/damages found on the product aside from the reported issue.There were no other products being utilized with the device.There was no excessive force used on the device.Flushing was done with normal result.The issue was reported to the doctor immediately and replaced the tube with the same product id and lot at the same day of the event as remedial action.The procedure was completed in icu (intensive care unit).There was no blood loss, and no blood transfusion was required.There was no intervention/treatment required as a result of the event.There was no reported patient injury.

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.

• 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: 19081176
• MDR Text Key: 340005278
• Report Number: 1282497-2024-00031
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2226500184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/02/2024
• Date Device Manufactured: 01/10/2023
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 50 KG