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

Model Number	8888135193
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2014
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, the hemodialysis catheter was introduced.However, when the guide wire was removed, it got stuck, unrolling all the wire, and it was necessary to remove the catheter with the wire, which was all rolled up and deformed.The catheter was not repaired and no leak.There was no reported patient outcome.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 11242683
• Report Number: 3009211636-2021-00026
• Device Sequence Number: 3966540
• Product Code: MPB
• UDI-Device Identifier: 10884521006492
• UDI-Public: 10884521006492
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030209
• 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): 01/28/2021

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: 04/30/2016
• Device Model Number: 8888135193
• Device Catalogue Number: 8888135193
• Device Lot Number: 109773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1