BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE

    MDR report key: 24504815 · Received March 4, 2026

    Report

    Report Number
    3010293992-2026-00013
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 6, 2026
    Report Date
    May 18, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FPA
    UDI-DI
    17290109159505
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED HISTORY RECORDS OF THE LOT USED BY THE CUSTOMER. INVESTIGATION FINDINGS: NO DESIGN OR MANUFACTURING DISCREPANCIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO A COMPLAINT OF THIS NATURE WERE IDENTIFIED. CONCLUSION: EITAN MEDICAL REQUESTED UNUSED SET OF THE SAME LOT (0881.0908.25) 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 FRANCE. A LEAKAGE ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5498 AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE ADMINISTRATION SET FPA EITAN MEDICAL LTD. 0881.0908.25 17290109159505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown