BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA EMPTY STERILE

    MDR report key: 2852828 · Received November 27, 2012

    Report

    Report Number
    1021343-2012-00157
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 14, 2012
    Manufacturer
    HOSPIRA INC.
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED DURING MANUAL FILLING OF THE VIAL AT THE USER FACILITY. THE CUSTOMER CONTACT REPORTED THAT THE VIAL WAS BEING FILLED WITH UNSPECIFIED VOLUMES OF DILAUDID 0.2 MG/ML AND NORMAL SALINE WHEN SOLUTION LEAKED FROM THE PROXIMAL END OF THE INJECTOR NEAR THE BLUE STOPPER IN THE VIAL. THE VIAL WAS REPLACED AND THE FILLING WAS RESUMED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA EMPTY STERILE 80MEA MEA HOSPIRA INC. NA 16248R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA