BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETRAC LXS YANKAUER

    MDR report key: 20294718 · Received September 24, 2024

    Report

    Report Number
    3007789561-2024-00001
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 10, 2024
    Manufacturer
    OBP MEDICAL CORPORATION
    Product Code
    JOL
    UDI-DI
    M648C1102200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT WAS MADE DIRECTLY TO FDA WITH ANONYMITY - CUSTOMER COMMUNICATION IS NOT POSSIBLE. LOT NUMBER WAS NOT PROVIDED SO DETAILED DEVICE HISTORY RECORD REVIEW CANNOT BE CONDUCTED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, PHOTOS WERE NOT PROVIDED, AND USER WAS NOT AVAILABLE TO PROVIDED ADDITIONAL DETAILS / RESPOND TO QUESTIONS, AND THE REPORTED FAILURE MODE WAS THEREFORE NOT CONFIRMED. A SAMPLE OF FINISHED DEVICES RECEIVED IN EVERY DELIVERY IS SUBJECTED TO A DESTRUCTIVE INCOMING INSPECTION, WHICH INCLUDES VISUAL PARTICULATE / CONTAMINATION INSPECTION (WHICH IS ALSO IMPLEMENTED IN PRODUCTION). A REVIEW OF NON-CONFORMING MATERIAL REPORTS CONFIRMED NO NCMR HAVE BEEN LOGGED FOR CONTAMINATION. A REVIEW OF COMPLAINT RECORDS CONFIRMED NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED OR OTHERWISE IDENTIFIED. A ROOT CAUSE CANNOT BE CONCLUDED - NOT ENOUGH INFORMATION WAS PROVIDED TO CONFIRM IMPLEMENTED RISK CONTROL MEASURES AND/OR PRODUCTION PROCESSES ARE INEFFECTIVE, NO ACTION PLAN IS DEEMED REQUIRED.

    Description of Event or Problem · 0

    COMPANY RECEIVED A COPY OF MEDWATCH FDA CARS GENERATED 3500-SERIES FORM - PROBLEM REPORT FROM MEDICAL DEVICE REPORTING TEAM, CDRH. PROBLEM DESCRIBED ON FORM AS FOLLOWS, "THE PRODUCT FROM OBP SURGICAL, "ONETRAC LXS YANKAUER" SHOULD BE STERILE AND INSIDE OF A STERILE PACKAGE. HOWEVER, ON NUMEROUS OCCASIONS STERILITY HAS BEEN COMPROMISED. IT HAS BEEN NOTED THAT THERE HAS BEEN HUMAN HAIR, AND OTHER DEBRIS INSIDE OF THE STERILE PACKAGING WHICH COULD RISK INFECTIONS AND OTHER COMPLICATIONS FOR THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290366 ONETRAC LXS YANKAUER YANKAUER SUCTION CANNULA JOL OBP MEDICAL CORPORATION NOT REPORTED M648C1102200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown