BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS

    MDR report key: 17106352 · Received June 12, 2023

    Report

    Report Number
    17106352
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 20, 2023
    Report Date
    May 31, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FAULTY IV EXTENSION TUBING LEAKED BLOOD ALL OVER. REGISTERED NURSE BELIEVES THERE WAS A HOLE IN IT. TUBING TOO CONTAMINATED TO KEEP, BUT PACKAGING WAS KEPT. VELANO VASCULAR EXT STABILIZED EXTENSION SET (REF 201-0016; LOT 9453666; EXPIRATION DATE 11/22/2025).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268800 EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON 9453666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown