BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20480365 · Received October 18, 2024

    Report

    Report Number
    20480365
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    March 13, 2024
    Report Date
    March 14, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN (REGISTERED NURSE) OPENED A BD PLASTI-PAK 3 ML LUER LOCK STERILE SYRINGE, LOT 3121510, FOR USE WITH A PATIENT. A DARK PARTICLE THAT LOOKED LIKE MOLD WAS NOTED INSIDE THE SYRINGE WHERE THE NEEDLE CONNECTS TO THE SYRINGE. SYRINGE WAS SAVED. PACKAGING WAS NOT SAVED. MANUFACTURER RESPONSE FOR BD 3 ML SYRINGE, BD PLASTIPAK 3ML LUER LOCK SYRINGE (PER SITE REPORTER). MEDLINE NOTIFIED. NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848215 BD LUER-LOK SYRINGE, PISTON FMF BECTON, DICKINSON AND COMPANY 309657 3121510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown