BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY CONTAINER 100ML

    MDR report key: 3151455 · Received May 30, 2013

    Report

    Report Number
    9613251-2013-00161
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    HOSPIRA, LTD
    Product Code
    KPE
    PMA / PMN Number
    K771228
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. ON AN UNSPECIFIED DATE AT THE COMPOUNDING FACILITY, THE EMPTY FLEXIBLE SOLUTION CONTAINER WAS FILLED WITH UNSPECIFIED VOLUMES OF FENTANYL CITRATE 2MCG/ML AND 0.1 PERCENT BUPIVACAINE FOR A TOTAL VOLUME OF 100ML. THE CUSTOMER CONTACT REPORTED THAT THE SOLUTION CONTAINER WAS PLACED IN A SHIPPING CONTAINER AND SHIPPED TO AN END USER. IT WAS REPORTED THAT AFTER THE SOLUTION CONTAINER WAS REMOVED FROM THE SHIPPING CONTAINER AT THE END USER, SOLUTION LEAKED FROM THE SEAM AT THE TOP OF THE SOLUTION CONTAINER. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238422 EMPTY CONTAINER 100ML 80KPE KPE HOSPIRA, LTD NA 22048NS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA