BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLE-FREE CONNECTOR

    MDR report key: 9595799 · Received January 16, 2020

    Report

    Report Number
    9616066-2020-00146
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    November 6, 2019
    Report Date
    November 6, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MC1000C-0006/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 MP1000C. THE 510K NUMBER PROVIDED IN SECTION G5 IS FOR THE DOMESTIC SIMILAR PRODUCT. K072542. A VISUAL INSPECTION OF BOTH SAMPLES DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR MANUFACTURING DEFECT WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S REPORT; THE PISTONS OF BOTH SAMPLES WERE RECEIVED IN THE CLOSED POSITION. THE SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTING BY CONNECTING AND DISCONNECTING THEM TO A 50ML BD PLASTIPAK SYRINGE FROM RETAINED BD STOCK AND FLUSHING THROUGH THE COMPONENT; IN EACH INSTANCE IT WAS NOTED THAT THERE WAS A SLIGHT DELAY BEFORE THE PISTON WOULD RETURN TO THE CLOSED POSITION FOLLOWING DISCONNECTION. 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. A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. 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 MAXPLUS PRODUCT.

    Description of Event or Problem · 1

    THE REPORTED FEEDBACK SUGGESTS THAT THE BLUE RUBBER SECTION IS NOT RETRACTING BACK INTO PLACE. THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61256 MAXPLUS CLEAR NEEDLE-FREE CONNECTOR SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION MP1000C-0006 19016586

    Patients

    Seq Age Sex Outcome Treatment
    1