BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 10485436 · Received September 2, 2020

    Report

    Report Number
    9616066-2020-02627
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 13, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A MZ1000 CHINA SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT LEAKAGE WAS IDENTIFIED DURING INFUSION. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19065894 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 IN THIS INSTANCE. WITHOUT A SAMPLE OR FURTHER INFORMATION IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE OR ADDITIONAL INFORMATION ABOUT THE EXACT NATURE OF THE DEFECT IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MAXZERO NEEDLELESS CONNECTOR LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE IS A LEAKAGE.

    Additional Manufacturer Narrative · 1

    MZ1000 CHINA/NO 510K THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IN SECTION D4 IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS MZ1000-07.THE 510K NUMBER PROVIDED IN SECTION G5 IS FOR THE DOMESTIC SIMILAR PRODUCT.- K132413 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 · 1

    IT WAS REPORTED THAT MAXZERO NEEDLELESS CONNECTOR LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE IS A LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949298 MAXZERO NEEDLELESS CONNECTOR CONNECTOR FPA CAREFUSION MZ1000 CHINA 19065894

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200807| 20200807