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U.S. Department of Health and Human Services

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

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
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.
 
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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 Key9755885
MDR Text Key194371996
Report Number3009211636-2020-00057
Device Sequence Number1
Product Code MPB
UDI-Device Identifier10884521006447
UDI-Public10884521006447
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K030209
Number of Events Reported1
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 Date01/02/2024
Device Model Number8888135191
Device Catalogue Number8888135191
Device Lot Number1902800147
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/11/2020
Initial Date FDA Received02/26/2020
Date Device Manufactured02/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age80 YR
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