BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18G BD INSYTE IV 1.16 IN LENGTH

    MDR report key: 22052110 · Received May 20, 2025

    Report

    Report Number
    MW5170602
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 15, 2025
    Report Date
    May 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN 18 G BD INSYTE IV ONGOING CONCERNS. TWO (2) NEEDLESTICKS HAVE OCCURRED, ONE IN (B)(6) 2024 AND ONE IN (B)(6) 2025. THERE HAVE BEEN SEVERAL NEAR MISSES. A LOT 5010456 WAS RETURNED IN MARCH WITH THESE CONCERNS REPORTED TO BD. PICTURE OF LOT RETURNED INCLUDED BELOW. (B)(6) ANOTHER NEAR MISS WAS REPORTED WITH LOT 5017998. SPEAKING WITH STAFF ON (B)(6) AND 5/16 THEY HAVE HAD ONGOING DIFFICULTY ENGAGING SAFETY MECHANISM, NEEDLE SLOW TO RETRACT, GETTING STUCK HALFWAY IN CATHETER, OR NOT RETRACTING AT ALL. REF REPORT: MW5170601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78425 18G BD INSYTE IV 1.16 IN LENGTH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other