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 No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient suffered from renal insufficiency and respiratory failure and during continuous renal replacement therapy (crrt) after catheter placement, it was found that there were two needle-shaped holes oozing blood at the venous end (distal end) of the femoral vein catheter.They had to immediately change the catheter as a preliminary treatment.There was no reported patient outcome.

Event Description

According to the reporter, the patient suffered from renal insufficiency and respiratory failure, had catheter placement, and during continuous renal replacement therapy (crrt), it was found that there were two needles-shaped holes oozing blood at the venous end (distal end) of the femoral vein catheter.They had to immediately change or replace the catheter as a preliminary treatment.The new catheter was used successfully and the procedure was completed.There was no intervention/treatment required as a result of the leakage and blood transfusion was not required.There was no patient injury.

Manufacturer Narrative

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

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9564107
• MDR Text Key: 190120911
• Report Number: 3009211636-2020-00014
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

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: 06/01/2022
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 1717900126
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR