BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 23319354 · Received October 16, 2025

    Report

    Report Number
    9616066-2025-03115
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 13, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403224782
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    CORRECTION OF THE LOT NUMBER FROM 2509995 TO UNKNOWN SINCE THE ORIGINALLY REPORTED LOT WAS INCORRECT AND DID NOT MATCH ANY MANUFACTURING RECORDS. INVESTIGATION RESULT: ONE MZ1000 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; RESIDUAL FLUID WAS PRESENT WITHIN THE RETURNED DEVICE. THE CUSTOMER REPORTED THAT THE AFFECTED SAMPLE WAS FROM LOT 250995, HOWEVER THIS DID NOT MATCH THE MANUFACTURING RECORD FOR THE PRODUCT. THE CUSTOMER REPORTED THAT "THE IV FLUSH IS FLUSHING BACK.". NO CONNECTING PRODUCTS WERE RECEIVED TO ASSIST THE INVESTIGATION. THE RETURNED SAMPLE WAS SUBJECTED TO FUNCTIONAL TESTING BY PRIMING AND FLUSHING USING A 50ML BD PLASTIPAK SYRINGE AND NO RESTRICTION OR OCCLUSION OF FLOW WAS OBSERVED. THE SAMPLE WAS THEN FURTHER SUBJECTED TO PRESSURE TESTING, HOWEVER NO LEAKAGE WAS OBSERVED FROM THE COMPONENT THROUGHOUT TESTING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. PLEASE NOTE THE MAXZERO IS NOT A BACK CHECK VALVE AND UNDER CERTAIN CIRCUMSTANCES IT IS POSSIBLE FOR FLUID TO BACK FLOW INTO THE MAXZERO. AS STATED IN THE DIRECTIONS FOR USE "FLUSH THE MAXZERO AFTER EACH USE WITH NORMAL SALINE OR IN ACCORDANCE WITH FACILITY PROTOCOL." AND "FAILURE TO PROPERLY PRIME THE DEVICE CAN RESULT IN REFLUX". A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST THE MZ1000 PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO NEEDLELESS CONNECTOR HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV FLUSH IS FLUSHING BACK.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254251 BD MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. UNKNOWN 10885403224782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown