BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INFUSION SET SA200 W/O LL

    MDR report key: 14360491 · Received May 11, 2022

    Report

    Report Number
    2243072-2022-00669
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 26, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 5023031 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INFUSION SET SA200 W/O LL FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK FOREIGN OBJECT FOUND ON SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914961 BD INFUSION SET SA200 W/O LL INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown