BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2050369 · Received April 4, 2011

    Report

    Report Number
    3004209178-2011-80928
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    IT WAS REPORTED THAT THE CUSTOMER HAD TWO LEAKING RESERVOIRS. THE CUSTOMER STATED THAT HE WAS UNABLE TO PRIME THROUGH HIS INFUSION SET AND THAT HE HAD A HARD TIME FILLING TWO RESERVOIRS. THE CUSTOMER ALSO STATED THAT HE HAD LEAKING AT THE CONNECTION OF THE P-CAP AND THE RESERVOIRS. THE CUSTOMER FURTHER STATED THAT WHILE THE QUICK RELEASE AND TUBING DID NOT LOOK DAMAGED, HE HAD LEAKAGE OCCURRING IN BOTH AREAS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7776317

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR