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 02/20/2024

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 use, the short tube of venous end was ruptured and damaged.It was noted that there was a leak at the junction of extension tube and bifurcate.The catheter was not repaired.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 the reported issue.There was no excessive force used on the device.There was no cleaning agent used on the device.The insertion site was not treated prior to product placement.Tego was not utilized.Flushing was not done.There were no other products being utilized with the device.The clamp was moved periodically.There was no remedial action done.The device was replaced with the same lot at the same day of the event.The procedure treatment was completed.There was no blood loss, and no blood transfusion was required.There was no med ical intervention treatment provided to the patient due to the event.There was no reported patient injury.

Manufacturer Narrative

Additional information: h6 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 use, the short tube of venous end was ruptured and damaged.It was noted that there was a leak at the junction of extension tube and bifurcate.The catheter was not repaired.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 the reported issue.There was no excessive force used on the device.There was no cleaning agent used on the device.The insertion site was not treated prior to product placement.Tego was not utilized.Flushing was not done.There were no other products being utilized with the device.The clamp was moved periodically.There was no remedial action done.As a remedial action to resolve the issue, the device was replaced with the same lot at the same day of the event.The procedure/treatment was completed.There was no blood loss, and no blood transfusion was required.There was no medical intervention/treatment provided to the patient due to the event.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: 18966328
• MDR Text Key: 338458556
• Report Number: 3009211636-2024-00085
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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