BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3130904 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-94047
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED RESERVOIR. FOUND RESERVOIR TRANSFER GUARD NEEDLE OCCLUDED. UNABLE TO PERFORM PRE-FILL TEST. CHECKED TRANSFER GUARD NEEDLE FOR BURRS, HOOKS AND DULL NEEDLE. NONE WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN FROM THE RESERVOIR LEAKED DURING FILLING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232128 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8383003

    Patients

    Seq Age Sex Outcome Treatment
    1