BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY CONTAINER 250ML

    MDR report key: 3964073 · Received May 5, 2014

    Report

    Report Number
    9613251-2014-00099
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 7, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    KPE
    PMA / PMN Number
    K771228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND INVESTIGATED. TESTING FOUND A 1 INCH TEAR IN THE SEAM OF THE LOWER LEFT SEAM OF THE PRINTED SIDE OF THE CONTAINER. THE MOST PROBABLE CAUSE IS DUE TO POSSIBLE OVER PRESSURING DURING FILLING AND EXPOSURE TO EXTREME TEMPERATURE DURING TRANSPORTATION OR STORAGE AFTER FILLING. 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 AT THE COMPOUNDING FACILITY, THE EMPTY FLEXIBLE SOLUTION CONTAINER WAS FILLED WITH UNSPECIFIED VOLUMES OF FENTANYL CITRATE 2MCG/ML AND BUPIVACAINE HCL 0.125% IN NORMAL SALINE FOR A TOTAL VOLUME OF 250ML. THE CUSTOMER CONTACT REPORTED THAT THE SOLUTION CONTAINER WAS OVERWRAPPED, PLACED INTO AN PLACED IN AN INTERMEDIATE PRODUCT CARTON, THEN PLACED IN A SHIPPING CONTAINER, AND WAS SHIPPED TO THE HOMECARE PATIENT. AFTER AN UNSPECIFIED LENGTH OF TIME, WHEN THE SOLUTION CONTAINER WAS REMOVED FROM THE SHIPPER AND INTERMEDIATE CARTON, THE SOLUTION HAD LEAKED FROM THE SOLUTION CONTAINER. THE SOLUTION CONTAINER WAS REPLACED AND THE THERAPY WAS INITIATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268341 EMPTY CONTAINER 250ML 80KPE KPE HOSPIRA LTD. NA 340964W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA