BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE DETERGENT DOCKING STATION

    MDR report key: 2004373 · Received February 25, 2011

    Report

    Report Number
    1811755-2011-00600
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 27, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND IT WAS NOTICED THAT THE DRAIN HOSE HAD RECESSED OUT OF THE WALL BY ABOUT 12 INCHES, POSSIBLY FROM BEING TIED TO THE WATER LINE WHICH JERKS DURING DOCKING. THE HOSE WAS UNTIED FROM THE WATER LINE. SUGGESTIONS WERE MADE TO THE ACCOUNT TO THEIR PLUMBING DEPT TO REDUCE THE CHANCE OF THE DRAIN COMING OUT AGAIN. THE INSTRUCTIONS FOR USE FOR THE NEPTUNE WASTE SYSTEM PROVIDES THE FOLLOWING UNDER IMPORTANT SAFETY INSTRUCTIONS: SURGICAL FLUID WASTE IS POTENTIALLY INFECTIOUS AFTER COLLECTION. HANDLING BIOHAZARD WASTE IS POTENTIALLY DANGEROUS. THE BLOODBORNE PATHOGENS STANDARD, PROVIDED BY THE (B)(4), REQUIRES THAT ALL WORKERS, HAVING EXPOSURE TO POTENTIALLY INFECTIOUS MATERIALS SHOULD WEAR THE CORRECT PERSONAL PROTECTION EQUIPMENT AND BE OFFERED IMMUNIZATION AGAINST (B)(6). ADDITIONALLY, THESE WORKERS SHOULD RECEIVE TETANUS IMMUNIZATION AND BOOSTERS WHEN REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOCKING THE ROVER SURGICAL FLUID WASTE HAD SPRAYED ALL OVER THE WALL. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES TO THE USER IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE DETERGENT DOCKING STATION AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK