BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 15192187 · Received August 8, 2022

    Report

    Report Number
    MW5111341
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 3, 2022
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    UDI-DI
    00382903029952
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMAGING TECHNOLOGIST OPENED SEALED PACKAGE CONTAINING BD 10 ML SYRINGE LUER-LOK TIP SYRINGE LOT # 1111465, EXP DATE: 03/31/2026, (B)(4) AND DREW UP MEDICATION INTO SYRINGE. TECHNOLOGIST NOTICED FOREIGN BODY / DEBRIS FLOATING INSIDE CHAMBER OF SYRINGE. DIAGNOSIS FOR USE: BREAST BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950393 BD 10ML SYRINGE LUER-LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON AND COMPANY 302995 1111465 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown