BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA EMPTY STERILE

    MDR report key: 3842964 · Received March 13, 2014

    Report

    Report Number
    1021343-2014-00008
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 1, 2004
    Report Date
    February 12, 2014
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. IT WAS REPORTED THAT UNSPECIFIED VOLUME OF SOLUTION LEAKED DURING MANUAL FILLING OF THE VIAL AT THE USER FACILITY. THE CUSTOMER CONTACT REPORTED THE VIAL WAS BEING FILLED WITH UNSPECIFIED CONCENTRATION OF DILAUDID WHEN SOLUTION LEAKED AT THE LUER LOCK OF THE INJECTOR IN THE VIAL DURING FILLING. THE VIAL WAS REPLACED AND THE FILLING WAS RESUMED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151704 PCA EMPTY STERILE 80MEA MEA HOSPIRA, INC. NA 49208R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA