BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21G SAFETY PUSH BUTTON BLOOD COLLECTION KITS BUTTERFLY NEEDLES

    MDR report key: 24178015 · Received January 26, 2026

    Report

    Report Number
    MW5182759
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 16, 2026
    Report Date
    January 20, 2026
    Manufacturer
    GCB MEDICAL LLC
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNINTENDED AUTOMATIC NEEDLE RETRACTION DURING BLOOD DRAW (MULTIPLE OCCURRENCES) - LUER ADAPTOR IS NOT SECURE TO THE EXTENSION OF THE BUTTERFLY AND FALLS OUT REGULARLY - MULTIPLE COMPLAINTS OF LUER DETACHING FROM THE NEEDLE - COMPLAINTS OF LEAKAGE BETWEEN THE ADAPTER AND LUER DURING BLOOD DRAWS - LUER DOES NOT PLUG CORRECTLY AND CONTINUES TO LEAK AFTER BLOOD GAS DRAWS - HOLDER DETACHED FROM BUTTERFLY WHEN CHANGING TUBING CAUSING LEAKAGE - REVERSE BLOOD FLOW IN THE BUTTERFLY WHEN PUSHING BLOOD CULTURE BOTTLE INTO THE ADAPTER - UPON INSERTION OF THE NEEDLE, BLOOD SPLATTERS FROM THE BODY OF THE BUTTERFLY WHERE THE PUSH BUTTON IS LOCATED - MULTIPLE STAFF NEEDLESTICKS INJURIES DUE TO ABSENCE OF PROTECTIVE CAPS - NEEDLE RETRACTOR DOES NOT MOVE WHEN PUSH BUTTON ACTIVATED. PT CODE: 2462. DEVICE CODES: 1536;1371;2907;1250;1064;3015. REF REPORT: MW5182760.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237616 21G SAFETY PUSH BUTTON BLOOD COLLECTION KITS BUTTERFLY NEEDLES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA GCB MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other