BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3972492 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88844
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS RETURNING OUR CALL. ADVISED CUSTOMER THE REASON FOR THE CALL, CUSTOMER REPORTED ABOUT THE INFUSION SET CAP AND RESERVOIR WERE NOT CONNECTING OR CLICKING PROPERLY. CUSTOMER REPORTED ALSO ABOUT GETTING BUBBLES BUT WAS NOT SURE. CUSTOMER UNABLE TO REMEMBER. NO TROUBLE SHOOTING DONE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449495 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR