BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 22792159 · Received August 13, 2025

    Report

    Report Number
    22792159
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    April 27, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ATTEMPTED TO RETRACT NEEDLE ONCE 22G IV CATHETER WAS PLACED IN RIGHT AC [ANTECUBITAL] VEIN. NEEDLE SLIPPED OUT OF PLASTIC COVER AND WAS EXPOSED. UNABLE TO RE-COVER NEEDLE BEFORE DISPOSING IN SHARPS CONTAINER. SAFETY MECHANISM ON PIV [PERIPHERAL INTRAVENOUS LINE] WAS FUSED. RN COULD NOT ENGAGE SAFETY AND RISK SHARPS INJURY AS SHE HAD TO WITHDRAW THE NEEDLE FROM THE CATHETER WITHOUT ENGAGING THE SAFETY. NO OTHER REPORTED ISSUES WITH THIS LOT. BRAND: SMITHS MEDICAL JELCO 22G X 1 INCH. LOT #: 6103156. EXP DATE: 03-11-2027. GTIN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563888 JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ ICU MEDICAL, INC. 326010 6103156

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female