BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLASS NEEDLES, 30ML SINGLE USE

    MDR report key: 4888379 · Received June 29, 2015

    Report

    Report Number
    MW5043484
    Event Type
    Other
    Date Received
    June 29, 2015
    Report Date
    April 16, 2015
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FMI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION: REPORTING FRAGILITY OF GLASS NEEDLES IS MADE OF SHIPMENT OF STERILE EMPTY VIAL AND INJECTOR, 30 ML 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 THERE ARE SOME THAT THE GLASS IS BROKEN OR CRACKED. REPORTS FROM NURSES HAVE TOLD THE PHARMACY THAT WHEN MANIPULATING THESE NEEDLES, SOME HAVE BROKEN AS WELL. MEDICATION ADMINISTERED TO OR USED BY THE PT: NO. PT COUNSELING PROVIDED: UNK. RELEVANT MATERIALS PROVIDED: NONE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418963 GLASS NEEDLES, 30ML SINGLE USE FMI HOSPIRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1