BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FEMALE ADAPTOR

    MDR report key: 22108434 · Received May 29, 2025

    Report

    Report Number
    9616066-2025-01402
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 5, 2025
    Report Date
    August 5, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    70885403484140
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 A CRACK ON THE LUER, AND RETURNED PHOTO EVIDENCE OF THE CRACK ON MATERIAL 1022-091-032, LOT 3261187. UPON INITIAL VISUAL EXAMINATION, THE SET VERIFIED THE COMPLAINT OF COMPONENT DAMAGE. THE COMPLAINT DETAILS WERE FORWARDED TO THE MANUFACTURING SITE, NORTH AMERICA MOLDING CENTER (NAMC). NAMC PERFORMED A DEVICE HISTORY RECORD¿S REVIEW (DHR) OF BATCH # 3261187, INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCH INVOLVED IN THIS COMPLAINT MEETS ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WAS MANUFACTURED, AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. NAMC WAS UNABLE TO IDENTIFY A ROOT CAUSE FOR THE COMPONENT DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FEMALE ADAPTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT IDENTIFIED A CRACK ON THE LUER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596949 BD FEMALE ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 3261187 70885403484140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown