BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM POLY CS-57

    MDR report key: 21315 · Received April 19, 1995

    Report

    Report Number
    MW1005667
    Event Type
    Malfunction
    Date Received
    April 19, 1995
    Date of Event
    March 6, 1995
    Report Date
    March 20, 1995
    Manufacturer
    U.S. SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BAXTER HEALTHCARE CORP. RT 120 & WILSON RD. ROUND LAKE, IL 60073-0490. EVALUATION OF OTHER INFO. ENVIRONMENTAL FACTORS SUCH AS FLUORESCENT LIGHTING AND OZONE CAN AFFECT THE RUBBER SLEEVE STOPPER OF AN INJECTION SITE. SEE THE ATTACHED TECHNICAL SUMMARY PRTS79018 THAT ADDRESSES THIS ISSUE. THE RPTR MAY HAVE ALLOWED THE CONTAINERS TO BE EXPOSED TO THESE CONDITIONS FOR AN EXTENDED PERIOD OF TIME PRIOR TO THEIR USE. BAXTER HEALTHCARE HAS MFG SOME EMPTY VIAFLEX CONTAINERS UTILIZING A WHITE RUBBER SLEEVE STOPPER THAT MAY MAKE THE WHITENING OF THE RUBBER LESS VISIBLE. HOWEVER, THE SAME ENVIRONMENTAL FACTORS WOULD APPLY TO THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM POLY CS-57 PREMIUM POLY CS-57 AUTO SUTURE GAG U.S. SURGICAL CORP. CS-57 N4M107

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR