BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 10039643 · Received May 8, 2020

    Report

    Report Number
    9616066-2020-01397
    Event Type
    Malfunction
    Date Received
    May 8, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 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 SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT AN OCCLUSION WAS IDENTIFIED WHEN ATTEMPTING TO ACCESS THE MAXZERO DEVICE. THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE CONNECTING PRODUCTS 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 19056299 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. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IN THIS INSTANCE THE CONNECTING PRODUCT IN USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT AVAILABLE FOR INVESTIGATION AND THEREFORE IT COULD NOT BE DETERMINED IF IT MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. 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 MZ1000 PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MAXZERO NEEDLELESS CONNECTOR WAS USED AND THERE WAS AN OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE WAS AN OCCLUSION.

    Additional Manufacturer Narrative · 1

    MZ1000 (B)(6)/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. (B)(6) MEDICAL HOSPITAL. 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 WAS USED AND THERE WAS AN OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE WAS AN OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502598 MAXZERO NEEDLELESS CONNECTOR CONNECTOR FPA CAREFUSION MZ1000 CHINA 19056299

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4)