BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMEL INC

    MDR report key: 8546345 · Received April 24, 2019

    Report

    Report Number
    1924669-2019-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 17, 2019
    Manufacturer
    REMEL INC
    Product Code
    MDB
    PMA / PMN Number
    K032306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT PROVIDED, HOWEVER PICTURES OF THE DEVICE IN QUESTION WERE PROVIDED BY CUSTOMER ALONG WITH A LOT NUMBER. VISUALLY IT APPEARS THERE WAS A MALFUNCTION OF THE MEMBRANE. THE REVIEW OF THE BATCH RECORD WAS CONDUCTED AND ALL TESTING WAS FOUND TO BE WITHIN SPECIFICATIONS INCLUDING FOR MEMBRANE INTEGRITY. ADDITIONALLY, THERE ARE CAMERAS TO INSPECT THE MEMBRANE AND NO ISSUES WERE NOTED DURING PRODUCTION OF THE LOT. REVIEW OF CALIBRATION AND MAINTENANCE RECORDS FOUND EVERYTHING TO BE UP TO DATE. AFTER THE INVESTIGATION OF THE RECORDS CONCLUDED, THE CUSTOMER CONFIRMED NO ANOMALIES WERE SEEN PRIOR TO USE AND THEY ALSO STATED THEY WERE NOW UNSURE OF THE LOT NUMBER OF THIS SPECIFIC DEVICE. A REVIEW OF THE COMPLAINT DATABASE FOUND NO OTHER IDENTICAL COMPLAINTS ON THIS CONNECTOR FOR LAST FIVE YEARS. THE EXACT ROOT CAUSE OF THE MEMBRANE MALFUNCTION IS UNKNOWN. WE WILL CONTINUE TO MONITOR AND TREND FOR THIS DEFECT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO STATE THE FOLLOWING HAD OCCURRED: ON THE EVENING OF WEDNESDAY, MARCH 20TH AN EMPLOYEE WAS REMOVING A BOTTLE FROM THE VERSATREK UNIT. UPON REMOVING THE BOTTLE FROM THE INSTRUMENT, BLOOD SQUIRTED FROM THE BOTTLE ONTO THE EMPLOYEES FACE, GETTING INTO THE EMPLOYEE'S EYES. THE EMPLOYEE WAS WEARING GLOVES, A LAB COAT, AND THEIR PERSONAL GLASSES AT THE TIME OF THE INCIDENT. THE EMPLOYEE IMMEDIATELY WASHED THEIR FACE AND CONTACTED THE OCCUPATIONAL HEALTH DEPARTMENT. THE BOTTLE WAS A NEGATIVE BOTTLE BEING REMOVED AT THE END OF THE INCUBATION PERIOD THAT DID NOT CONTAIN ANY BACTERIAL GROWTH. THE CUSTOMER STATED THE CONNECTOR APPEARED TO BE MISSING THE TOP PIECE UPON REMOVAL. THE CUSTOMER IS ABLE TO SEE DIRECTLY DOWN INTO THE CONNECTOR, AND IT APPEARS THE NEEDLE IS VISIBLE FROM THE OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339431 REMEL INC VERSATREK CONNECTOR MDB REMEL INC 7150-44

    Patients

    Seq Age Sex Outcome Treatment
    1 Other