BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISS VACUUM LATCH VALVE

    MDR report key: 1943631 · Received December 13, 2010

    Report

    Report Number
    1419185-2010-15861
    Event Type
    Other
    Date Received
    December 13, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 1, 2010
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE INVESTIGATION: THIS DEFECT WAS CONFIRMED AT OHIO MEDICAL CORP WHEN EXISTING STOCK WAS PHYSICALLY CHECKED FOR CROSS CONNECTIONS AND THE DISS FITTING'S MEASUREMENTS WERE CHECKED AGAINST THE DRAWING. THE INNER DIAMETER OF THE DISS FITTING FOR PART # 261100-2, REVISION 2 IS OUT OF SPEC WHICH ALLOWS FOR THE CONNECTION OF MEDICAL AIR IN ADDITION TO VACUUM. EVAL OF EXISTING STOCK CONFIRMED THAT THE INNER DIAMETER (ID) OF THE DISS FITTING WAS OUT OF SPEC PER OHIO MEDICAL CORP'S DRAWING. THE DISS FITTING WAS OVERSIZED BY 1.0 MM. ENGINEERING PERSONNEL VISITED THE COMPONENT SUPPLIER AND CONFIRMED THAT A FACTORY ERROR CAUSED THIS DIMENSIONAL NON-CONFORMITY. OHIO MEDICAL CORP CONFIRMED THAT THE SUPPLIER WAS PROVIDED WITH THE APPROVED DRAWING FOR THE DISS VACUUM LATCH VALVE ON 5/27/2008. (B)(4). COMPLAINT HISTORY REVIEW: THIS IS THE FIRST REPORTED COMPLAINT OF THIS NATURE TO OHIO MEDICAL CORP. THESE OUTLETS WERE NOT IN USE AT THE TIME THE DEFECT WAS IDENTIFIED. THERE ARE NO KNOWN INJURIES OR ADVERSE EVENTS ASSOCIATED WITH THIS PART DEFECT. CONCLUSION: THERE ARE MULTIPLE REDUNDANT LAYERS OF SAFETY FEATURES IN PLACE DESIGNED TO PREVENT AND ALSO DETECT ERRORS IN MEDICAL GAS CONNECTIONS. SAFETY MEASURES SUCH AS GAS OUTLET/FITTING COLOR CODING, AUDIBLE ALARMS, PT MONITORING, AND THE PRACTICE OF DEVICE SET UP OCCURRING OFF-PT ARE REDUNDANT WAYS TO DETECT AND NOTIFY USERS OF A CONNECTION ERROR PRIOR TO USE ON A PT. NEVERTHELESS, OHIO MEDICAL CORP HAS MADE THE DECISION TO PROVIDE REPLACEMENTS FOR ALL AFFECTED DISS VACUUM LATCH VALVES (PART # 261100-2, REVISION 2) IN THE FIELD, DESPITE THE ASSESSMENT THAT THERE IS A VERY LOW LIKELIHOOD OF AN UNDETECTED CONNECTION ERROR AND THE CORRESPONDING PT SAFETY RISK. FURTHERMORE, THE ROOT CAUSE HAS BEEN IDENTIFIED AND CORRECTED WITH THE SUPPLIER. AFFECTED INVENTORY, NOT MEETING SPEC FOR THE ID, HAS BEEN QUARANTINED AND WILL BE DISPOSITIONED AS SCRAP.

    Description of Event or Problem · 1

    DISS LATCH VALVE FOR VACUUM, PART # 261100-2 REV 2, HAS THE CORRECT COLOR CODING PER (B)(4) BUT IT HAS A DIMENSIONAL NON-CONFORMANCE THAT ALLOWS THE CONNECTION OF MEDICAL AIR FITTINGS. THE DIAMETER INDEX SAFETY SYSTEM (DISS) IS INTENDED TO PHYSICALLY PREVENT THE CROSS-CONNECTION OF GAS FITTINGS. A THIRD PARTY MEDICAL GAS CERTIFIER DETERMINED THAT THE VACUUM DISS VALVE THEY WERE CERTIFYING WAS CAPABLE OF ACCEPTING BOTH VACUUM AND MEDICAL AIR ADAPTER DISS FITTINGS. THIS PRODUCT SHOULD ONLY BE ABLE TO ACCEPT A VACUUM ADAPTER DISS FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISS VACUUM LATCH VALVE DISS VACUUM LATCH VALVE BTA OHIO MEDICAL CORPORATION 261100-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other