BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 10039650 · Received May 8, 2020

    Report

    Report Number
    9616066-2020-01624
    Event Type
    Malfunction
    Date Received
    May 8, 2020
    Date of Event
    April 17, 2020
    Report Date
    April 17, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . MZ1000 NO 510K THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED 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 IS FOR THE DOMESTIC SIMILAR PRODUCT.- K132413. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT A CRACK WAS IDENTIFIED TO THE MAXZERO DEVICE WHICH RESULTED IN LEAKAGE DURING USE. THE CONNECTING PRODUCT WAS NOT RETURNED TO ASSIST THE INVESTIGATION. ROOT CAUSE ANALYSIS: 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 DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. PREVIOUS INVESTIGATIONS HAVE IDENTIFIED THAT RECESSED PISTONS CAN OCCUR AS A RESULT OF A CORE PIN MISMATCH WHICH RESULTS IN A SLIGHT STEP BEING FORMED WITHIN THE COMPONENT. AS A RESULT, WHEN THE PISTON IS DEPRESSED IT CAN BE CAUGHT ON THE STEP AND REMAIN IN THE RECESSED POSITION WHEN DISCONNECTED. IN THIS INSTANCE A LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. AS A RESULT OF SIMILAR FEEDBACK, THE MANUFACTURING SITE HAVE REFURBISHED THE MOULDING TOOL AND TIGHTENED THE SPECIFICATION OF THE ASSEMBLY PROCESS IN ORDER TO ENSURE REPORTS OF THIS NATURE ARE REDUCED IN FUTURE. INVESTIGATION CONCLUSION: THE PISTON OF THE MAXZERO DEVICE REMAINED IN THE RECESSED POSITION FOLLOWING DISCONNECTION FROM THE MALE LUER COMPONENT. THE CONNECTING PRODUCT WAS NOT RETURNED TO ASSIST THE INVESTIGATION. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST THE MAXZERO PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MAXZERO NEEDLELESS CONNECTOR BLUE SILICONE VALVE WOULD NOT RETURN TO THE ORIGINAL POSITION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE CUSTOMER USED MZ, IT WAS FOUND THAT BLUE SILICONE VALVE DOESN¿T RETURN TO ORIGINAL POSITION AND IT KEPT COLLAPSED. NO INFORMATION FOR USED PERIOD, CONNECTED DEVICE AND USED MEDICATION WAS PROVIDED FROM THE CUSTOMER. NO HEALTH HAZARD TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502603 MAXZERO NEEDLELESS CONNECTOR CONNECTOR FPA CAREFUSION MZ1000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other