BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMLINE

    MDR report key: 742619 · Received May 25, 2005

    Report

    Report Number
    MW1035531
    Event Type
    Injury
    Date Received
    May 25, 2005
    Date of Event
    April 20, 2005
    Report Date
    May 18, 2005
    Manufacturer
    TRIMLINE MEDICAL PRODUCTS
    Product Code
    FKB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT WAS CONNECTED TO A PHILIPS MONITOR, WHICH INCLUDES EKG, RR, SPO2, AND NIBP. THE PT TOOK THE NIBP HOSE AND CONNECTED THIS TO HIS IV TUBING AT THE CLAVE CONNECTION BY UTILIZING THE DUAL TUBE ADAPTER APPLIED TO THE CABLE. HAD THIS NOT BEEN DISCOVERED BEFORE THE MACHINE CYCLED, THE PT COULD HAVE SUSTAINED A FATAL AIR EMBOLUS. ORIGINALLY THESE ADAPTERS MADE AND SUPPLIED BY TRIMLINE. PART# 9204, ADAPTS SINGLE TUBE BAYONET TO DUAL TUBE MALE -PUSH-LUER, SO THAT THE FACILITY COULD UTILIZE JUST ONE TYPE OF DISPOSABLE CUFFS WITH ALL OF OUR MAKES AND MODELS OF NIBP PRODUCTS. WE HAVE CHANGED OUT OUR DISPOSABLE CUFFS FOR THOSE WITH BAYONET FOR SINGLE TUBE APPLICATIONS ONLY, REMOVED AND DESTROYED ALL DUAL ADAPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMLINE 9204 ADAPTER - SINGLE TUBE MALE BAYONET TO DUAL TUBE MALE LU FKB TRIMLINE MEDICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R