BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MALE LL ADAPTOR

    MDR report key: 19761899 · Received July 17, 2024

    Report

    Report Number
    9616066-2024-00991
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 14, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    70885403483822
    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

    THE CUSTOMER REPORTED EMBEDDED PARTICLES AND PROVIDED PHOTOS OF MATERIAL 1001-145-022. THE PHOTOS WERE EXAMINED AND THE COMPLAINT WAS VERIFIED. THE INFORMATION WAS PASSED TO THE NORTH AMERICA MOLDING CENTER (NAMC), IN AN EFFORT TO REDUCE THE LIKELIHOOD OF THE ISSUE OCCURRING DURING FUTURE PRODUCTION. THIS PRODUCT WAS MANUFACTURED BY A FORMER SUPPLIER, (B)(4), AND PREVIOUS DHR INFORMATION DID NOT INDICATE ANY REPORTED ISSUES. THE ROOT CAUSE FOR THE ISSUE WAS NOT ABLE TO BE FOUND. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT. SHOULD THERE BE ANY ADDITIONAL QUESTIONS AS IT RELATES TO THIS PR (B)(4), PLEASE CONTACT YOUR SALES SUPPORT REPRESENTATIVE, (B)(4) AT (B)(4).

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MALE LL ADAPTOR HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: IT WAS REPORTED BY CUSTOMER THAT EMBEDDED PARTICLES LARGER THAN 0.2 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354473 BD MALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 0004117078 70885403483822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown