BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSI-STOP INJECTION NEEDLE

    MDR report key: 23271330 · Received October 10, 2025

    Report

    Report Number
    1220592-2025-00002
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 10, 2025
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    FBK
    PMA / PMN Number
    K834403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE OF POSI-STOP INJECTION NEEDLE 4708, LOT H03-24-008, THE PROXIMAL LUER FITTING DISCONNECTED FROM THE HANDLE CANNULA/INNER SHEATH OF THE DEVICE. THE MALFUNCTION OCCURRED WHILE BOTOX WAS BEING ADMINISTERED THROUGH THE NEEDLE, WHICH RESULTED IN LESS OF THE DRUG BEING ADMINISTERED THAN INTENDED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BRAND OF NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227367 POSI-STOP INJECTION NEEDLE ENDOSCOPIC INJECTION NEEDLE FBK HOBBS MEDICAL, INC. H03-24-008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BOTOX