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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number 8888222216
Medical Device Problem Codes Material Frayed (1262); Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/24/2020
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 catheter had flow problems, usually after second dialysis the catheter was not able to use, leading to frequent changes every two dialysis on average.The guide wire was not rigid, making it difficult to pass, in addition to rupture in the procedure.There was no reported patient injury.
 
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Brand Name
MAHURKAR ELITE
Common Device Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
CR  20101
MDR Report Key10776987
Report Number3009211636-2020-00268
Device Sequence Number1088147
Product Code MPB
UDI-Device Identifier10884521125834
UDI-Public10884521125834
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K120674
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/03/2020
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
Operator of Device Health Professional
Device Expiration Date11/07/2022
Device Model Number8888222216
Device Catalogue Number8888222216
Device Lot Number1733700118
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/19/2020
Initial Report FDA Received Date11/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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