BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2091322 · Received May 4, 2011

    Report

    Report Number
    3004209178-2011-81326
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN WAS LEAKING FROM THE TRANSFER GUARD NEEDLE WHILE FILLING THE RESERVOIR. THE CUSTOMER STATED THAT HE TOSSED OUT FOUR RESERVOIRS, BUT HE KEPT ONE RESERVOIR TO RETURN. THE CUSTOMER STATED THAT THE RESERVOIRS LEAK AND WILL NEITHER EFFECTIVELY INSERT AIR INTO AN INSULIN VIAL NOR WITHDRAW THE INSULIN FROM THE VIAL WITHOUT BREAKING. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7734204

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR