BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA EMPTY STERILE

    MDR report key: 3854002 · Received June 6, 2014

    Report

    Report Number
    1021343-2014-00015
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 1, 2012
    Report Date
    April 4, 2012
    Manufacturer
    HOSPIRA, INC. REG NO: 1021343
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    Z-2346-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED ON (B)(4) 2012 AND EVALUATED. TESTING FOUND THAT SOLUTION LEAKED FROM THE FLANGE OF THE INJECTOR WHEN PRESSURE WAS APPLIED. 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 EXPOSURE TO ELEVATED TEMPERATURE IN COMBINATION WITH A POOR ULTRAVIOLET CURE. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. (B)(4). 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 AN 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 AN UNSPECIFIED MEDICATION WHEN SOLUTION LEAKED FROM A HOLE AT THE TOP OF THE INJECTOR IN THE VIAL. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE VIAL WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332331 PCA EMPTY STERILE MEA MEA HOSPIRA, INC. REG NO: 1021343 13170R1

    Patients

    Seq Age Sex Outcome Treatment
    1