BEUDAMED
    FDA Adverse Event Other Summary report: N

    JELCO - 24G PROTECTIV PLUS SAFETY IV CATHETER-RADIOPAQUE

    MDR report key: 18779186 · Received February 26, 2024

    Report

    Report Number
    MW5151933
    Event Type
    Other
    Date Received
    February 26, 2024
    Date of Event
    February 21, 2024
    Report Date
    February 22, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SAFETY FUNCTION OF PIV (PERIPHERAL INTRAVASCULAR) CATHETER NEEDLE COVER FAILED. THIS MALFUNCTION CAUSED A NEEDLE STICK INJURY TO THE HEALTHCARE PERSONNEL AND SKIN ABRASION/SCRAPE TO A NEWBORN PATIENT. THE NURSE CORRECTLY ACTIVATED THE NEEDLE COVER, BUT THE NEEDLE STAYED EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289880 JELCO - 24G PROTECTIV PLUS SAFETY IV CATHETER-RADIOPAQUE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ SMITHS MEDICAL ASD, INC. 4422644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown