BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 10570587 · Received September 22, 2020

    Report

    Report Number
    9616066-2020-02860
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 1, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A MZ1000 SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER THE CUSTOMER PROVIDED A VIDEO OF THE AFFECTED SAMPLE. ANALYSIS OF THE VIDEO CONFIRMED THE CUSTOMER'S EXPERIENCE WITH LEAKAGE OBSERVED BETWEEN THE CONNECTION OF THE MAXZERO AND A SYRINGE. NO OBVIOUS CRACKS OR DAMAGE WERE VISIBLE WHICH MAY HAVE CONTRIBUTED TO THE LEAKAGE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20016945 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAULT. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT IN ORDER TO BE AWARE OF THE REPORTED FEEDBACK DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE MZ1000 PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXZERO NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING THE PRODUCT, IT SHOWED A LEAK IN THE CONNECTION WITH THE SYRINGE. A TOTAL OF 3 UNITS WERE USED, WHICH CONTINUED TO HAVE THE SAME PROBLEM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXZERO NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING THE PRODUCT, IT SHOWED A LEAK IN THE CONNECTION WITH THE SYRINGE. A TOTAL OF 3 UNITS WERE USED, WHICH CONTINUED TO HAVE THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035761 MAXZERO NEEDLELESS CONNECTOR NEEDLELESS CONNECTOR FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20016945

    Patients

    Seq Age Sex Outcome Treatment
    1 Other