BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20782415 · Received November 26, 2024

    Report

    Report Number
    20782415
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 5, 2024
    Report Date
    October 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IV TECH FOUND SOMETHING ODD ON A 50ML BD IV SYRINGE -LOT# 4183156, EXPIRATION: [REDACTED DATE]. IT IS A WHITE SPOT ON THE INSIDE OF THE SYRINGE (NOT ON PLUNGER) -LOOKS LIKE IT COULD BE SOMETHING OR JUST A PLASTIC ABNORMALITY. SENT PICTURES AND ESCALATED TO PEDIATRIC PHARMACY MOC. SEQUESTERED SYRINGE. MANUFACTURER RESPONSE FOR 50ML SYRINGE, (BRAND NOT PROVIDED) (PER SITE REPORTER) EMAILED REP ON [REDACTED DATE] AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573988 BD LUER-LOK SYRINGE, PISTON FMF BECTON, DICKINSON AND COMPANY 309653 4183156

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose