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

Model Number 8888135191

Device Problem Fluid/Blood Leak (1250)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the initial hemodialysis, it was found that the catheter had a crack and had leaked from an unspecified location.The procedure was stopped upon knowing of the event.The treatment was continued and completed after product replacement was done.The patient had experienced an increase in pain as a result of the event.The catheter was not repaired but was replaced to resolve the issue.There was no reported patient injury.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 9755885
• MDR Text Key: 194371996
• Report Number: 3009211636-2020-00057
• 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: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2020

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 Expiration Date: 01/02/2024
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 1902800147
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 02/26/2020
• Date Device Manufactured: 02/21/2019
• 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: 80 YR