BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 24299225 · Received February 9, 2026

    Report

    Report Number
    9616066-2026-00277
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 18, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403230196
    PMA / PMN Number
    K132413
    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

    INVESTIGATION RESULTS: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 0

    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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO NEEDLELESS CONNECTOR HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 PATIENT'S IV PIGTAIL BECAME DISCONNECTED AT THE LUER LOCK CONNECTION. PATIENT WAS BLEEDING INTO BED LINENS. NEW BD PIGTAIL WAS SUPPLY USED. (B)(6) 2020 TIME 0000 PATIENT 2 PATIENT'S IV PIGTAIL BECAME DISCONNECTED AT THE LUER LOCK CONNECTION. PATIENT WAS BLEEDING INTO BED LINENS. NEW BD PIGTAIL WAS SUPPLY USED. (B)(6) 2021 TIME 1200 PATIENT 3 PATIENT'S IV PIGTAIL BECAME DISCONNECTED AT THE LUER LOCK CONNECTION. PATIENT WAS BLEEDING INTO BED LINENS. NEW BD PIGTAIL WAS SUPPLY USED. (B)(6) 2021 TIME 1748 OCCURRENCES IN NUC MED AND FSED ALSO IN ADDITION TO 3 PATIENTS IN MED SURG UNIT. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE REACTIONS OR SERIOUS INJURIES. CAN YOU PLEASE CONFIRM THE TOTAL NUMBER OF PATIENTS AFFECTED IN NUC MED AND FSED? 6 DOCUMENTED CONTAMINATIONS ON IMAGING, THERE HAVE BEEN OTHERS WHERE WE "CATCH" THE CONTAMINATION IN OUR GLOVE AND MEASURE IT. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT FOR OCCURRENCES IN NUC MED AND FSED IN MM-DD-YYYY FORMAT? (B)(6) 2025 (X2), (B)(6) 2025, (B)(6) 2025, (B)(6) 2025, (B)(6) 2025 (X2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374216 BD MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. UNKNOWN 10885403230196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown