BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG INJECTION SITE WITH LUER LOCK

    MDR report key: 31972 · Received April 12, 1996

    Report

    Report Number
    MW1008866
    Event Type
    Malfunction
    Date Received
    April 12, 1996
    Date of Event
    February 20, 1996
    Report Date
    April 2, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BAXTER HEALTHCARE CORP. RT 120 & WILSON RD, ROUND LAKE IL 60073-0490. ADD'L INFO: THE REPORT FROM THE CUSTOMER INDICATED THAT THE SEPARATION OF THE SLEEVE STOPPER FROM THE INJECTION SITE OCCURRED WHEN AN AUTOINJECTOR WAS BEING USED TO INJECT CONTRAST MEDIA THROUGH THE INJECTION SITE. THE LABELING FOR THE INJECTION SITE HAS THE CAUTION STATEMENT "DO NOT APPLY EXCESSIVE INTERNAL PRESSURE." IT IS KNOWN THE AUTOINJECTORS CAN EXERT PRESSURES WELL IN EXCESS OF 100 PSI. THIS EXESSIVE PRESSURE WAS THE LIKELY CAUSE OF THE SEPARATION OF THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG INJECTION SITE WITH LUER LOCK MALE ADAPTER FOZ BAXTER HEALTHCARE CORP. 95 K24 H20

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other