BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD RIGID TIP SUCTION WAND

    MDR report key: 2773430 · Received September 28, 2012

    Report

    Report Number
    2028837-2012-00004
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 28, 2012
    Manufacturer
    CALIFORNIA MEDICAL LABORATORIES, INC.
    Product Code
    DTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES ARE ON ROUTE TO OUR FACILITY. ONCE RECEIVED, THE DEVICES WILL BE DECONTAMINATED AND SUBSEQUENTLY AN INVESTIGATION WILL BE INITIATED TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT.

    Description of Event or Problem · 1

    THE TIP OF THE SUCTION WANDS ARE LOOSE AND COMING OFF DURING OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD RIGID TIP SUCTION WAND STANDARD RIGID TIP SUCTION WAND DTS CALIFORNIA MEDICAL LABORATORIES, INC. SU-12202NS S120197N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other