BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE EMPTY VIAL AND INJECTOR 30ML

    MDR report key: 4724195 · Received April 16, 2015

    Report

    Report Number
    MW5042197
    Event Type
    Injury
    Date Received
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SHIPMENT OF STERILE EMPTY VIAL AND INJECTOR, 30ML SINGLE USE, FOR THE USE WITH A COMPATIBLE HOSPIRA PCA PUMP SET WITH INJECTOR AND A COMPATIBLE HOSPIRA INFUSION DEVICE. MADE BY HOSPIRA INC. ONE/LIST NO. 6021-03. THESE LARGE GLASS NEEDLES ARE VERY FRAGILE, WHEN A SHIPMENT COMES IN TO THE PHARMACY, THERE ARE SOME OF THE GLASS NEEDLES THAT ARE BROKEN OR CRACKED DESPITE THEIR PROTECTIVE PACKAGING. REPORTS FROM NURSES HAVE TOLD THE PHARMACY THAT WHEN MANIPULATING THESE NEEDLES, SOME HAVE BROKEN AS WELL. MEDICAL DEVICE USED COMMONLY IN THE HOSPITAL, DURING MANIPULATION AND EVEN FROM SHIPMENT, SOME ARE BROKEN/CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253043 STERILE EMPTY VIAL AND INJECTOR 30ML STERILE EMPTY VIAL MEA HOSPIRA, INC.
    253190 STERILE EMPTY VIAL AND INJECTOR 30ML STERILE EMPTY VIAL KYX 18-364-R1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PCA PUMP