BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULAS

    MDR report key: 20639073 · Received November 8, 2024

    Report

    Report Number
    3007697975-2024-00008
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 14, 2024
    Report Date
    October 22, 2024
    Manufacturer
    EUROMI SA
    Product Code
    GEA
    UDI-DI
    03701416203340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH FILE DOES NOT SHOW ANY ANOMALY IN THE EXECUTION OF THE MANUFACTURING STEPS. THE INCIDENT ENCOUNTERED CONCERNS A BROKEN CANNULA AT THE BASE: THE BASE BRAZING STEP WAS CARRIED OUT ON (B)(6) 2024 BY (B)(6), A TRAINED OPERATOR. (B)(4) CANNULA WAS DISCARDED AT THIS STAGE FOR THE FOLLOWING REASON: CLOGGED CANNULA. THIS REJECT WAS NOT RELATED TO THE INCIDENT OBSERVED. NO OTHER INCIDENTS WERE REPORTED AT THIS STAGE, AND QUALITY CONTROL AT THIS STAGE IS IN COMPLIANCE (VISUAL VERIFICATION OF THE WELD). IN ADDITION, A DESTRUCTIVE TEST IS CARRIED OUT EVERY (B)(4) CANNULAS, FOR EACH REFERENCE. FOR THIS REFERENCE, THE LAST DESTRUCTIVE TEST WAS CARRIED OUT ON LOT 23AOFI013L4, ON (B)(6)2023, AND IS COMPLIANT. THE NEXT TEST IS PLANNED FOR LOT 24APHI008OL4 (CURRENTLY IN PRODUCTION). WELDING OF THE BASEPLATE IS A MANUAL, UNITARY OPERATION. AS NO OTHER COMPLAINTS HAVE BEEN RECORDED ON THIS BATCH, WE CAN CONCLUDE THAT THIS IS AN ISOLATED DEFECT.

    Description of Event or Problem · 0

    CANNULA BREAKAGE AT BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876137 CANNULAS REUSABLES CANNULAS GEA EUROMI SA 24APCI008L4 03701416203340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown