BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MALE ADAPTOR

    MDR report key: 23866479 · Received December 22, 2025

    Report

    Report Number
    9616066-2025-03870
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 25, 2025
    Report Date
    January 5, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED 54 INSTANCES OF BROKEN MALE LUER ON MATERIAL 1001-078-004, LOT 5103445. THE RETURNED SAMPLES WERE INVESTIGATED AT (B)(6), AND THE DEFECT WAS CONFIRMED. THE MANUFACTURING PLANT WAS UNABLE TO TRACE THE REPORTED ISSUE TO THE MANUFACTURING PROCESS. THE ROOT CAUSE IS UNKNOWN. THIS WAS THE ONLY BATCH THAT WAS EXECUTED FOR THIS PART CODE, AND THERE WERE MATERIAL CHANGES BEFORE AND AFTER THE PRODUCTION OF THIS RUN. NAMC PERFORMED A DEVICE HISTORY RECORD (DHR) REVIEW ON BATCH #5103445 FOR COMPONENT 1001-078-004, WHICH INCLUDES ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL'S), WERE MANUFACTURED, AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. QN QUERY FOR THE BROKEN LUER CONDITION WAS PERFORMED IN ALL THE AFFECTED BATCHES, AND NO HISTORY OF THE DEFECT WAS DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MALE ADAPTOR WAS BROKE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT BROKEN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716158 BD MALE ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 5103445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown