BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, HYPO TW 18GX1 1/2", 1.20X38MM SB

    MDR report key: 3952309 · Received July 3, 2014

    Report

    Report Number
    2523676-2014-00251
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER STATES, "I WAS DRAWING UP BCG FOR A (B)(6) INJECTION WHEN THE NEEDLE SNAPPED OFF FROM THE HUB. IT WAS IN THE BOTTLE OF THE MEDICATION. WHEN I LOOKED DOWN THE NEEDLE WAS STICKING OUT OF THE OUTER PART OF MY LEFT WRIST." REFERENCE MFR REPORT 9610825-2014-00251.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390495 NEEDLE, HYPO TW 18GX1 1/2", 1.20X38MM SB STANDARD HYPODERMIC NEEDLES FMI B. BRAUN MELSUNGEN AG NA 3K11258841

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK