BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO

    MDR report key: 18130121 · Received November 14, 2023

    Report

    Report Number
    9616066-2023-02189
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    August 31, 2023
    Report Date
    December 21, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403285851
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF PR 9160654, IN WHICH THE CUSTOMER HAS STATED: ¿A NEWLY OPENED MZ1000 CONNECTOR WITH A PRE-FILLED SYRINGE ATTACHED REVEALED THAT THE FLUID WOULD NOT INJECT¿. THE PRODUCT IN USE AT THE TIME IS REPORTED TO BE A MZ1000 CHINA FROM LOT 22045853. 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 22045853 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 MZ1000 CHINA PRODUCTS IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MAX ZERO WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER AND TRANSLATED INTO ENGLISH: A NEWLY OPENED MZ1000 CONNECTOR WITH A PRE-FILLED SYRINGE ATTACHED REVEALED THAT THE FLUID WOULD NOT INJECT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION: IT WAS REPORTED THAT BD MAX ZERO WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER AND TRANSLATED INTO ENGLISH: A NEWLY OPENED MZ1000 CONNECTOR WITH A PRE-FILLED SYRINGE ATTACHED REVEALED THAT THE FLUID WOULD NOT INJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926763 BD MAXZERO INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 22045853 10885403285851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown