BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 24200341 · Received January 28, 2026

    Report

    Report Number
    9616066-2026-00148
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 5, 2026
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULT: A MZ1000 CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER, THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 25045151. THE FEEDBACK PROVIDED BY THE CUSTOMER STATES THAT, "THESE CONNECTORS EXHIBITED RESISTANCE DURING INJECTION AND FAILED TO DELIVER FLUID SMOOTHLY". NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 25045151 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE TO EXAMINE IT HAS NOT BEEN POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE; HOWEVER, A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE PRODUCT MZ1000 CHINA IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT IS REPORTED OCCLUSION. DESCRIPTION: ON (B)(6), WARD (B)(4) ENCOUNTERED ISSUES WITH TRANSPARENT NEEDLE-FREE CONNECTORS MANUFACTURED BY KANG'ERFUSHENG (SHANGHAI) TRADING CO., LTD. WHEN CONNECTED TO SYRINGES, THESE CONNECTORS EXHIBITED RESISTANCE DURING INJECTION AND FAILED TO DELIVER FLUID SMOOTHLY. AFTER RULING OUT PATIENT-RELATED FACTORS AND OTHER POTENTIAL CAUSES, THE OBSTRUCTION PERSISTED. USE OF THE PRODUCT WAS IMMEDIATELY DISCONTINUED, AND THE AFFECTED SUPPLIES WERE REPLACED. THE PROBLEMATIC CONNECTORS WERE SEALED AND SUBMITTED TO THE MEDICAL EQUIPMENT DEPARTMENT FOR RETURN TO THE MANUFACTURER FOR RE-INSPECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264318 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 25045151 10885403224782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown