BEUDAMED
    FDA Adverse Event Other Summary report: N

    BITE PROOF BITE BLOCK

    MDR report key: 2656045 · Received June 21, 2012

    Report

    Report Number
    2938401-2012-00002
    Event Type
    Other
    Date Received
    June 21, 2012
    Date of Event
    April 8, 2012
    Report Date
    May 29, 2012
    Manufacturer
    B & B MEDICAL TECHNOLOGIES, INC.
    Product Code
    JAY
    PMA / PMN Number
    K873491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT AVAILABLE FOR EVAL. EVENT OCCURRED ON (B)(6) 2012, HOWEVER, WAS NOT REPORTED TO B & B MEDICAL TECHNOLOGIES UNTIL 5/10/2012. EACH BITE PROOF BITE BLOCK IS PACKAGED WITH INSTRUCTIONS FOR USE. PRINTED ON THE INSTRUCTIONS FOR USE IS A CAUTION NOTICE THAT STATES: "SHOULD CUFF FILLING PROBLEM OCCUR, GENTLY PULL THE PILOT BALLOON TUBE TAUT TO REMOVE ANY KINKS." SINCE 05/10/2009, B&B HAS SOLD OVER 300,000 EACH BITE PROOF BITE BLOCKS. (B)(6) MEDICAL CENTER HAS BEEN THE FIRST USER FACILITY TO REPORT CUFF RELATED ISSUES WITH USE OF THE BITE PROOF BITE BLOCK.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PHYSICIANS AT THE (B)(6) WERE UNABLE TO WITHDRAW AN ENDOTRACHEAL TUBE FROM A PT DURING A PLANNED EXTUBATION. THE CUFF WAS DEFLATED TWICE AND THE ENDOTRACHEAL TUBE STILL COULD NOT BE WITHDRAWN. THE LINE TO PORT USED TO INFLATE THE PILOT BALLOON WAS CUT AND THEN THE ENDOTRACHEAL TUBE WAS WITHDRAWN. IT WAS FOUND THAT THE PILOT BALLOON TUBE WAS PINCHED IN BETWEEN THE ENDOTRACHEAL TUBE AND THE B&B BITE PROOF BITE BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BITE PROOF BITE BLOCK BITE BLOCK JAY B & B MEDICAL TECHNOLOGIES, INC. 11040 D133437

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other