BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO

    MDR report key: 24617534 · Received March 17, 2026

    Report

    Report Number
    2243072-2026-00210
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 26, 2026
    Report Date
    April 2, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    10885403230660
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS MDR, BD FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS THE MANUFACTURING SITE IS UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: SEE D TAB. G.4. 510K: K140831.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS CRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684499 MAXZERO SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON 25039189 10885403230660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown