MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	8888345629
Medical Device Problem Codes	Material Frayed (1262); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the hemodialysis catheter had a failure.It was mentioned that there was bleeding at the application site, breakage of the guide wire, and inadequate flow of blood supply.The use of the product followed the instructions of the manufacturing service and there were no product changes.There was no reported patient outcome.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 11824531
• Report Number: 3009211636-2021-00104
• Device Sequence Number: 19121063
• Product Code: NIE
• UDI-Device Identifier: 10884521006799
• UDI-Public: 10884521006799
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K020089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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 Expiration Date: 09/06/2023
• Device Model Number: 8888345629
• Device Catalogue Number: 8888345629
• Device Lot Number: 1827600090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1