BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER

    MDR report key: 23836122 · Received December 18, 2025

    Report

    Report Number
    3010293992-2025-00083
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 18, 2025
    Report Date
    February 15, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FPA
    UDI-DI
    17290109159512
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED SETS OF THE SAME TYPE AND LOT. INVESTIGATION FINDINGS: NO LEAKAGE OR OTHER ISSUES WERE OBSERVED IN ANY OF THE SETS. CONCLUSION: THE COMPLAINT WAS NOT CONFIRMED. THE SETS WERE VISUALLY INSPECTED AND PHYSICALLY TESTED. NO LEAKAGE OR OTHER ISSUES WERE OBSERVED IN ANY OF THE SETS. 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.

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL REQUESTED UNUSED SETS OF THE SAME TYPE AND LOT NUMBERS FOR INVESTIGATION. ONCE PROVIDED, FURTHER INVESTIGATION WILL BE CONDUCTED, AND THE INVESTIGATION FINDINGS WILL BE SUBMITTED IN THE 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 CANADA. A LEAKAGE ISSUE WAS REPORTED. NO HUMAN HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM CANADA. A LEAKAGE ISSUE WAS REPORTED. NO HUMAN HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246206 AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER ADMINISTRATION SET FPA EITAN MEDICAL LTD. 1364.1805.14 17290109159512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown