BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROBORE INFUSION SET WITH NON-VENTED SPIKE

    MDR report key: 21482509 · Received February 27, 2025

    Report

    Report Number
    MW5167028
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    February 22, 2025
    Report Date
    February 24, 2025
    Manufacturer
    EITAN MEDICAL LTD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SAPPHIRE INFUSION TUBING LEAKAGE. AP240-0. REF: (B)(4) LOT: 1355.2406.14. EXP: 2026/12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649145 MICROBORE INFUSION SET WITH NON-VENTED SPIKE SET, ADMINISTRATION, INTRAVASCULAR FPA EITAN MEDICAL LTD 1355-2406-14

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention