BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET

    MDR report key: 17904977 · Received October 10, 2023

    Report

    Report Number
    9616066-2023-02025
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 26, 2023
    Report Date
    November 8, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403230561
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THE SETS ARE LEAKING ONCE CONNECTED TO THE SYRINGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL MZ5303 LOT NUMBER 23039152 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 32003 UNITS IN 1 LOT NUMBER WAS BUILT ON 09MAR2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. H.3. 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

    NO ADDITIONAL INFORMATION: IT WAS REPORTED WHILE USING BD MAXZERO¿ MULTI-FUSE EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS CONTINUING TO HAVE PROBLEMS WITH THE IV EXTENSION MZ5303( (10) 23039152) SET AS THEY ARE LEAKING ONCE CONNECTED TO THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MAXZERO¿ MULTI-FUSE EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS CONTINUING TO HAVE PROBLEMS WITH THE IV EXTENSION MZ5303( (10) 23039152) SET AS THEY ARE LEAKING ONCE CONNECTED TO THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332179 BD MAXZERO¿ MULTI-FUSE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 23039152 10885403230561

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown