BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER SLIP TIP SYRINGE STERILE, SINGLE USE, 1 ML

    MDR report key: 16618248 · Received March 24, 2023

    Report

    Report Number
    MW5115971
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    March 21, 2023
    Report Date
    March 22, 2023
    Manufacturer
    BECTON-DICKINSON AND COMPANY
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I NOTICED VISIBLE CONTAMINATION ON AN UNOPENED STERILE BD 1 ML TUBERCULIN SLIP-TIP SYRINGE (REF (B)(4)). THE LOT NUMBER IS 2203500. OUR LAB USES THESE SYRINGES IN PROKARYOTIC MICROBIAL RESEARCH WITH NO DIRECT HUMAN HEALTH APPLICATIONS, BUT I FELT THAT IT WOULD BE IMPORTANT TO REPORT THIS. I CAN'T ASCERTAIN WHETHER THE RESIDUE IS ONLY ON THE OUTSIDE OF THE SYRINGE OR ACTUALLY INSIDE THE TIP WITHOUT OPENING THE STERILE WRAPPER, WHICH I DIDN'T THINK I SHOULD DO WITHOUT REPORTING THIS FIRST. ALL I CAN SAY WITH CERTAINTY IS THAT THE DISCOLORATION IS ON THE SYRINGE ITSELF, NOT JUST THE INSIDE OF THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486335 LUER SLIP TIP SYRINGE STERILE, SINGLE USE, 1 ML SYRINGE, PISTON FRN BECTON-DICKINSON AND COMPANY 309659 2203500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown