BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER BATH TRAY

    MDR report key: 2986458 · Received February 26, 2013

    Report

    Report Number
    1719045-2013-10006
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    JTQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION VISUAL INSPECTION REVEALED THE RETURNED UNIT SHOWED GENERAL WEAR ON ALL OUTSIDE SURFACES INCLUDING SCRATCHES AND DINGS. THE UNIT SHOWED DISCOLORATION/SPOTTING AND MINOR SCRATCHES ON INSIDE SURFACES. THE UNIT IS SIGNIFICANTLY BENT IN ONE CORNER OF THE TOP FLANGE, WHICH WOULD PREVENT THE UNIT FROM FUNCTIONING PER SPECIFICATION. THIS BENT CORNER IS NOT A RESULT OF ANY MANUFACTURING PROCESSES. THE UNIT SHOWS SOME DISCOLORATION ON THE LASER ETCHED WATER LEVEL LINES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WATER BATH TRAY WAS RETURNED TO THE OFFICE AFTER THE HOSPITAL COMPLAINED THAT THE WATER LEVEL LINE IN THE TRAY WAS SHOWING SIGNS OF RUST. THEY NOTED THAT THE RUST SEEMED TO BE LEACHING INTO STERILE WATER WHEN THE BATH WAS FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81752 WATER BATH TRAY JTQ SYNTHES (USA) MONUMENT 5101604

    Patients

    Seq Age Sex Outcome Treatment
    1