BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY CONTAINER 1-L

    MDR report key: 3823381 · Received March 20, 2014

    Report

    Report Number
    9613251-2014-00065
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    KPE
    PMA / PMN Number
    K771228
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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. THE EMPTY FLEXIBLE CONTAINER WAS FILLED AT THE COMPOUNDING FACILITY WITH NORMAL SALINE AND 18 MILLION UNITS OF PENICILLIN GK FOR A TOTAL FILL VOLUME OF 900 ML. IT WAS REPORTED THAT THE FILLED FLEXIBLE CONTAINERS WERE SHIPPED IN INSULATED FREEZER BOXES TO PREVENT FREEZING OF THE DRUG SOLUTION. THE CUSTOMER CONTACT REPORTED THAT WHEN THE HOMECARE PATIENT OPENED THE DELIVERY CARTON, SOLUTION LEAKED FROM A HOLE IN THE SEAM BETWEEN THE ADDITIVE PORT AND THE CORNER OF THE FLEXIBLE CONTAINER. THE FLEXIBLE CONTAINER WAS NOT USED BY THE PATIENT. THE FLEXIBLE SOLUTION CONTAINER WAS REPLACED WITH ANOTHER CONTAINER THAT THE HOMECARE PATIENT HAD IN STOCK AND THE THERAPY WAS INITIATED AS ORDERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167765 EMPTY CONTAINER 1-L 80KPE KPE HOSPIRA, LTD. NA 343274W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK