BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPY PACK

    MDR report key: 131609 · Received August 4, 1997

    Report

    Report Number
    MW4002040
    Event Type
    Malfunction
    Date Received
    August 4, 1997
    Report Date
    August 4, 1997
    Manufacturer
    MAXXIM MEDICAL, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BOUNDARY/MAXXIM OPERATING ROOM DRAPES AND SURGICAL GOWNS ARE NOT IMPERVIOUS TO BLOOD AND BODY FLUIDS, RESULTING IN STRIKE THROUGH TO THE WEARERS CLOTHING AND SKIN. THIS IS IN DIRECT VIOLATION OF THE 1991 BLOOD BORN PATHOGENS ACT, OSHA, AND JCAHO REQUIREMENTS. REQUEST THAT THE SURGICAL PACKS AND GOWNS FROM MAXXIM BE REPLACED BY PRODUCTS MADE BY ANOTHER CO'S. THE REPLACEMENT PRODUCTS ARE CONSTRUCTED WITH STATE-OF-THE-ART 4TH GENERATION FABRIC. UNLIKE PAPER DISPOSABLE PRODUCTS, THEIR TECHNOLOGY DELIVERS BREATHABLE BARRIER PERFORMANCE THAT IS SECOND-TO-NONE. STUDIES SHOW THAT REPLACEMENT CO'S DISPOSABLE PRODUCTS ARE SO ADVANCED THAT EVEN THEIR NON-REINFORCED PRODUCTS PROVIDE BETTER PROTECTION THAN COMPETITORS FABRIC-REINFORCED PRODUCTS. FOR EXAMPLE, IN EXTENSIVE LAB BLOOD STRIKE THROUGH TESTING AT 2 PSI, 1% OF BLOOD WILL STRIKE THROUGH SUSPECTS SURGICAL GOWNS, VERSUS FROM 52% TO 85% ON OTHER PRODUCTS TESTED. WHEN TESTED WITH WATER UNDER INCREASING PRESSURE, BOTH NON-REINFORCED AND FABRIC-REINFORCED REPLACEMENT PRODUCTS SHOW MORE THAN TWICE THE LEVEL OF RESISTANCE TO PENETRATION COMPARED TO PAPER PRODUCTS TESTED. THIS SUPERIOR ABILITY IN PREVENTING FLUID PENETRATION CAN BE EXTREMELY IMPORTANT WHEN LONG PERIODS OF TIME ARE SPENT LEANING AGAINST WET SURFACES IN THE OPERATING ROOM. SAFETY AWARENESS, EDUCATION AND THE USE OF PRODUCTS THAT ARE RESISTANT TO RAPID FLAME SPREAD ARE IMPORTANT STEPS IN OVERALL OPERATING ROOM SAFETY. ACCORDING TO THE CPSC TEST FOR FLAMMABILITY MOST PRODUCTS FALL UNDER CLASS 1. UNFORTUNATELY, SO DOES NEWSPAPER. AMONG LEADING SINGLE-USE PRODUCTS, ONLY REPLACEMENT CO'S FABRIC MEETS THE MORE STRINGENT CLASS 1 REQUIREMENTS OF NFPA 702-1980.

    Description of Event or Problem · 1

    BOUNDRY/MAXXIM OPERATING ROOM DRAPES AND SURGICAL GOWNS ARE NOT IMPERVIOUS TO BLOOD AND BODY FLUIDS, RESULTING IN STRIKE THROUGH TO THE WEARERS CLOTHING AND SKIN. THIS IS IN DIRECT VIOLATION OF THE 1991 BLOOD BORNE PATHOGENS ACT, OSHA, AND JCAHO REQUIREMENTS. REQUEST THAT THE SURGICAL PACKS AND GOWNS FROM MAXXIM BE REPLACED BY PRODUCTS MADE BY ANOTHER CO'S. THE REPLACEMENT PRODUCTS ARE CONSTRUCTED WITH STATE-OF-THE-ART 4TH GENERATION FABRIC. UNLIKE PAPER DISPOSABLE PRODUCTS, THEIR TECHNOLOGY DELIVERS BREATHABLE BARRIER PERFORMANCE THAT IS SECOND-TO-NONE. STUDIES SHOW THAT REPLACEMENT CO'S DISPOSABLE PRODUCTS ARE SO ADVANCED THAT EVEN THEIR NON-REINFORCED PRODUCTS PROVIDE BETTER PROTECTION THAN COMPETITORS FABRIC-REINFORCED PRODUCTS. FOR EXAMPLE, IN EXTENSIVE LAB BLOOD STRIKE THROUGH TESTING AT 2 PSI, 1% OF BLOOD WILL STRIKE THROUGH SUSPECTS SURGICAL GOWNS, VERSUS FROM 52% TO 85% ON OTHER PRODUCTS TESTED. WHEN TESTED WITH WATER UNDER INCREASING PRESSURE, BOTH NON-REINFORCED AND FABRIC-REINFORCED REPLACEMENT PRODUCTS SHOW MORE THAN TWICE THE LEVEL OF RESISTANCE TO PENETRATION COMPARED TO PAPER PRODUCTS TESTED. THIS SUPERIOR ABILITY IN PREVENTING FLUID PENETRATION CAN BE EXTREMELY IMPORTANT WHEN LONG PERIODS OF TIME ARE SPENT LEANING AGAINST WET SURFACES IN THE OPERATING ROOM. SAFETY AWARENESS, EDUCATION AND THE USE OF PRODUCTS THAT ARE RESISTANT TO RAPID FLAME SPREAD ARE IMPORTANT STEPS IN OVERALL OPERATING ROOM SAFETY. ACCORDING TO THE CPSC TEST FOR FLAMMABILITY MOST PRODUCTS FALL UNDER CLASS 1. UNFORTUNATELY, SO DOES NEWSPAPER. AMONG LEADING SINGLE-USE PRODUCTS, ONLY REPLACEMENT CO'S FABRIC MEETS THE MORE STRINGENT CLASS 1 REQUIREMENTS OF NFPA 702-1980.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPY PACK SURGICAL DRAPE KKX MAXXIM MEDICAL, INC. * C0357
    2 E.E.N.T. PACK SURGICAL DRAPE KKX MAXXIM MEDICAL, INC. * C1637
    3 EXTREMITY PACK SURGICAL DRAPE KKX MAXXIM MEDICAL, INC. * C0507A
    4 LAPAROTOMY PARK SURGICAL PACK KKX MAXXIM MEDICAL, INC. * B5435
    5 SPLIT SHEET SURGICAL DRAPE KKX MAXXIM MEDICAL, INC. * C1077
    6 DRAPE SHEET MEDIUM SURGICAL DRAPE KKX MAXXIM MEDICAL, INC. * 61866
    7 SURGICAL GOWN LARGE SURGICAL GOWN LARGE FYA MAXXIM MEDICAL, INC. * H07018
    8 SURGICAL GOWN XL SURGICAL GOWN XL FYA MAXXIM MEDICAL, INC. * 7020
    9 C-SECTION PACK (BACK-UP) SURGICAL DRAPE KKX MAXXIM MEDICAL, INC. * C0837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA
    2