BEUDAMED
    FDA Adverse Event Injury Summary report: N

    B&B MEDICAL

    MDR report key: 2561692 · Received May 2, 2012

    Report

    Report Number
    MW5025286
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    April 1, 2012
    Report Date
    April 18, 2012
    Manufacturer
    B&B MEDICAL TECHNOLOGIES, BY: INTEGRA BIOTECHNICAL, LLC
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIVERSAL SITE BLOCK SLIPPED DOWN DEEPLY INTO THE OROPHARYNX AND THROUGH IT WAS VISIBLY SEEN. IT WAS NOT RETRIEVABLE. ANESTHESIA WAS CALLED IMMEDIATELY AND ENDOTRACHEAL TUBE WAS PROMPTLY REMOVED AND THE PT WAS REINTUBATED. OUR OBSERVATION IS THAT THE CABLE TIE, THOUGH VERY SNUG, DID NOT ADEQUATELY PREVENT THE BITE BLOCK FROM SLIPPING DOWN THE SIZE #7 ENDOTRACHEAL TUBE INTO THE OROPHARYNX; NO SAFE GUARD TO PREVENT POTENTIAL RISK. ADDITIONALLY, WITH THE NEWER ORDERS OF THE SITE BLOCK, WE NOTICED THE OPENING SLOT IS WIDER WHICH MAY ALSO POSSIBLY BE CONTRIBUTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B&B MEDICAL UNIVERSAL SITE BLOCK JXL B&B MEDICAL TECHNOLOGIES, BY: INTEGRA BIOTECHNICAL, LLC 11160 ADULT D134204

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention