BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    MDR report key: 1812959 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-82481
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED USED RESERVOIR AND PERFORMED MANUAL PRIME AND HIGH-PRESSURE TESTS. THE RESERVOIR PASSED THE TESTS AND NO LEAKS ON BOTH O-RINGS WERE OBSERVED DURING ANALYSIS. THE RESERVOIR CONNECTED AND LOCKED IN PLACE PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RESERVOIR WAS LEAKING WHILE SHE WAS FILLING IT UP. THE CUSTOMER STATED THAT SHE HAD ALREADY RESOLVED THE ISSUE BY CHANGING OUT THE RESERVOIR. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-326A 10PK PRDGM 1.8ML 13L DISPOSABLES FMF MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A H7637360

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR