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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 8888223216
Medical Device Problem Code Product Quality Problem (1506)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/24/2019
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, prior to use, customer complained that the suture wing could not be folded normally.It was stated that the catheter were not repaired, there was no leak, tego was not utilized, and there was no adapter issue.There was no reported patient involvement.
 
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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
MDR Report Key8357760
Report Number3009211636-2019-00042
Device Sequence Number1954366
Product Code MPB
UDI-Device Identifier10884521125926
UDI-Public10884521125926
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K120674
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/21/2019
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 Date03/23/2020
Device Model Number8888223216
Device Catalogue Number8888223216
Device Lot Number1510300090
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/25/2019
Initial Report FDA Received Date02/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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