BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 10429252 · Received August 19, 2020

    Report

    Report Number
    9616066-2020-02464
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 30, 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
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FIFTY-TWO MZ1000 SAMPLES FROM LOT 17087743 WERE RECEIVED FOR INVESTIGATION OF COMPLAINTS (B)(4); FORTY-NINE SAMPLES WERE RECEIVED IN SEALED PACKAGING, AND THREE SAMPLES IN OPENED PACKAGING. ADDITIONALLY TWO BD INSYTE AUTOGUARD CATHETERS AND ONE CRANBERRY THREE-WAY TAP WERE RECEIVED IN OPENED PACKAGING TO ASSIST THE INVESTIGATION. A VISUAL INSPECTION OF ALL THE SAMPLES RECEIVED DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. EACH OF THE RETURNED MZ1000 SAMPLES IN OPENED PACKAGING WERE SUBJECTED TO PRESSURE TESTING IN ORDER TO REPLICATE THE LEAKAGE, NO LEAKAGE WAS OBSERVED THROUGHOUT TESTING. THE SAMPLES WERE THEN CONNECTED TO THE RETURNED BD INSYTE AUTOGUARD AND THE CRANBERRY THREE-WAY TAP AND AGAIN SUBJECTED TO PRESSURE TESTING; NO LEAKAGE WAS OBSERVED FROM THE CONNECTION OF EITHER OF THE PRODUCTS THROUGHOUT TESTING. ADDITIONALLY THE TESTING PROCEDURE WAS PERFORMED WITH 10 OF THE RETURNED MZ1000 SAMPLES IN SEALED PACKAGING; NO LEAKAGE WAS IDENTIFIED THROUGHOUT TESTING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 17087743 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE IN THIS INSTANCE. TESTING OF THE RETURNED SAMPLES DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. IN THIS INSTANCE THE CUSTOMER'S EXPERIENCE COULD NOT BE REPLICATED AND THEREFORE IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXZERO NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT INSTALLS PERIPHERAL VENOUS LINE FOR LESS THAN 2 YEARS, SHE ADDS A DEVICE TO CONNECT PERIPHERAL VENOUS LINE WITH PHLEBOCOLYSIS, BUT WHEN STARTING FLUID THERAPY IT FILTERS IN THE DISTAL CONNECTION, SHE CONNECTS AND DISCONNECTS REPEATEDLY, THINKING THAT IT WAS POORLY CONNECTED, BUT IT CONTINUES TO FILTER, FINALLY, AND NOT TO REMOVE PERIPHERAL VENOUS LINE, SHE CONNECTS A THREE-WAYS VALVE (CONNECTOR), NOW SHE CONNECTS FLUID THERAPY, ACHIEVING ADMINISTRATION WITHOUT PROBLEMS. 1 PATIENT INVOLVED, MALE GENDER; DEVICE HAS NOT BEEN RE-USED (INITIAL USAGE).

    Additional Manufacturer Narrative · 1

    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 AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT INSTALLS PERIPHERAL VENOUS LINE FOR LESS THAN 2 YEARS, SHE ADDS A DEVICE TO CONNECT PERIPHERAL VENOUS LINE WITH PHLEBOCOLYSIS, BUT WHEN STARTING FLUID THERAPY IT FILTERS IN THE DISTAL CONNECTION, SHE CONNECTS AND DISCONNECTS REPEATEDLY, THINKING THAT IT WAS POORLY CONNECTED, BUT IT CONTINUES TO FILTER, FINALLY, AND NOT TO REMOVE PERIPHERAL VENOUS LINE, SHE CONNECTS A THREE-WAYS VALVE (CONNECTOR), NOW SHE CONNECTS FLUID THERAPY, ACHIEVING ADMINISTRATION WITHOUT PROBLEMS. 1 PATIENT INVOLVED, MALE GENDER; DEVICE HAS NOT BEEN RE-USED (INITIAL USAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888983 MAXZERO NEEDLELESS CONNECTOR NEEDLELESS CONNECTOR FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 17087743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200628| 20200628