BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA ST EMPTY VIAL

    MDR report key: 3231056 · Received July 12, 2013

    Report

    Report Number
    1021343-2013-00069
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 13, 2013
    Manufacturer
    HOSPIRA INC., HOSPITAL PRODUCTS DIVISION
    Product Code
    MEA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFO 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 A COMPOUNDING FACILITY, THE VIAL WAS FILLED WITH DILAUDID 1 MG/ML FOR A TOTAL VOLUME OF 30 ML AND WAS SHIPPED TO THE END USER. ON AN UNSPECIFIED DATE, THE VIAL WAS LOADED INTO A PATIENT CONTROLLED ANALGESIA (PCA) PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME WHEN THE DELIVERY WAS COMPLETE, THE VIAL WAS REMOVED FROM THE PUMP. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THAT SOLUTION LEAKED FROM AN UNSPECIFIED LOCATION ON THE VIAL AND WAS NOTED AT THE FLANGE ON THE INJECTOR IN THE VIAL AND AT THE BOTTOM OF THE SYRINGE HOLDER OF THE PUMP. THE VIAL WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324761 PCA ST EMPTY VIAL 80MEA MEA HOSPIRA INC., HOSPITAL PRODUCTS DIVISION NA UNKR1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK