BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE

    MDR report key: 24741712 · Received March 31, 2026

    Report

    Report Number
    3010293992-2026-00026
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 20, 2026
    Report Date
    March 31, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL HAS REQUESTED THE DEVICE FOR INVESTIGATION. HOWEVER, THE DEVICE WAS NOT PROVIDED BY THE CUSTOMER. AS A RESULT, A COMPREHENSIVE INVESTIGATION OF THIS EVENT COULD NOT BE CONDUCTED. IF THE DEVICE WILL BE PROVIDED BY THE CUSTOMER, AN INVESTIGATION WILL BE CONDUCTED, AND THE INVESTIGATION'S FINDINGS WILL BE PRESENTED IN A FOLLOW UP REPORT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K141834.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. HUMAN HARM WAS REPORTED; HOWEVER NO FURTHER INFORMATION WAS PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799152 AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE ADMINISTRATION SET FPA EITAN MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown