BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA ST EMPTY VIAL

    MDR report key: 3231093 · Received July 12, 2013

    Report

    Report Number
    1021343-2013-00070
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    HOSPIRA INC., HOSPITAL PRODUCTS DIVISION
    Product Code
    MEA
    PMA / PMN Number
    K042800
    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 30ML, AND SHIPPED TO THE END USER. ON (B)(6) 2013, IT WAS REPORTED THAT AFTER AN UNSPECIFIED SEAL OF THE VIAL WAS BROKEN AND THE YELLOW CAP ON THE VIAL WAS REMOVED, THE PHARMACIST NOTED LESS THAN 0.25 ML OF MOISTURE AT AN UNSPECIFIED LOCATION INSIDE THE VIAL. THE CUSTOMER CONTACT REPORTED THAT WHEN THE INJECTOR WAS INSERTED INTO THE BLUE STOPPER OF THE VIAL, A FEW DROPS OF SOLUTION LEAKED AROUND THE BLUE STOPPER IN THE VIAL. 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 PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323502 PCA ST EMPTY VIAL 80MEA MEA HOSPIRA INC., HOSPITAL PRODUCTS DIVISION NA UNKR1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK