MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	8830415001
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during dialysis treatment in the hospital, the doctor reported that the catheter was installed 24 hours ago, but when the patient tried to remove it, the winglets were broken it detached from the catheter, which meant that the securement wings of the catheter were broken but the fixing points remained on the skin (the catheter did not move out of place).The treatment was not completed. there was no leak, and there was no luer adapter issue.Nothing unusual was observed on the device prior to use.No other products were being utilized with the device.The catheter was not repaired.No cleaning agent was used on the device.Tego was not utilized.The insertion site was treated with betadine prior to product placement.The ring of the suture wing did not break. the catheter was removed as a remedial action to resolve the issue.The product was not replaced.There was no blood loss.A blood transfusion was not required.No intervention or medical treatment was required as a result of the event.There was no reported patient injury.
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.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 19117587
• Report Number: 1282497-2024-00047
• Device Sequence Number: 7112301
• Product Code: FOZ
• UDI-Device Identifier: 10884521005150
• UDI-Public: 10884521005150
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K943349
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8830415001
• Device Catalogue Number: 8830415001
• Device Lot Number: 2227200189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/16/2024
• Date Device Manufactured: 11/07/2022
• 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: Unknown