BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS,KIT,ACCESSORY,SAN DIEGO

    MDR report key: 19169426 · Received April 23, 2024

    Report

    Report Number
    3015173212-2024-00002
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 23, 2024
    Manufacturer
    MEDLINE - MEXICALI
    Product Code
    LRO
    UDI-DI
    40193489444002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER "THE 3ML SYRINGES ARE NOT RETAINING PLUNGER PORTION WHEN PULLED BACK TO FILL. THE ENTIRE STEM SHOOTS OUT WHEN IT SHOULD HAVE A LIP INTERNALLY IN THE BARREL OF THE SYRINGE TO RETAIN THE PLUNGER PORTION". A SAMPLE IS AVAILABLE FOR EVALUATION. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER "THE 3ML SYRINGES ARE NOT RETAINING PLUNGER PORTION WHEN PULLED BACK TO FILL. THE ENTIRE STEM SHOOTS OUT WHEN IT SHOULD HAVE A LIP INTERNALLY IN THE BARREL OF THE SYRINGE TO RETAIN THE PLUNGER PORTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948228 MTS,KIT,ACCESSORY,SAN DIEGO LRO MEDLINE - MEXICALI 24BMB179 40193489444002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown