BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA EMPTY STERILE

    MDR report key: 2941272 · Received January 31, 2013

    Report

    Report Number
    1021343-2013-00026
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    HOSPIRA INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    Z-2346-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE WAS DISCARDED. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS THE ISSUE OF LEAKAGE FROM THE INJECTOR IN THE STERILE EMPTY VIAL. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT SOLUTION LEAKAGE FOUND AT THE CANNULA AND THE POLYPROPYLENE INJECTOR BODY WAS DUE TO ADHESIVE SHRINKAGE AND SEPARATION FROM THE INJECTOR. THE ADHESIVE SHRINKAGE AND SEPARATION WAS DUE TO ELEVATED TEMPERATURE IN COMBINATION WITH A POOR ULTRAVIOLET CURE. AS INDICATED, THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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. IT WAS REPORTED THAT 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 AN UNSPECIFIED CONCENTRATION VERSED WHEN THE SOLUTION LEAKED, PROXIMAL TO THE FLANGE OF THE INJECTOR 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
    43462 PCA EMPTY STERILE 80MEA MEA HOSPIRA INC. NA 16423R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA