BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL BITE BLOCK

    MDR report key: 3001268 · Received January 30, 2013

    Report

    Report Number
    2938401-2012-00004
    Event Type
    Other
    Date Received
    January 30, 2013
    Date of Event
    November 8, 2012
    Report Date
    January 25, 2013
    Manufacturer
    B&B MEDICAL TECHNOLOGIES/INTEGRA BIOTECHNICAL, LLC.
    Product Code
    JXL
    PMA / PMN Number
    K960663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEWING THE ANECDOTAL REPORT SUBMITTED BY THE USER AND A COMPREHENSIVE REVIEW AND STATISTICAL ANALYSIS OF THE DEVICE HISTORY RECORDS, SPANNING BACK THREE (3) YRS FOR THIS DEVICE, WE HAVE DETERMINED THE FOLLOWING: THE COMPLAINT RATE IS TWO (2), INCLUDING THIS COMPLAINT, IN 421,000. THE OTHER WAS OF A SIMILAR NATURE, THE CAP WAS FOUND IN THE PT'S MOUTH. THAT'S A COMPLAINT RATE OF .00000475%. THIS STATISTICALLY DEMONSTRATES THE SAFETY AND EFFICACY OF THE PRODUCT. AFTER REVIEWING OF THE DEVICE HISTORY RECORDS, LOT# D224213 SHOWED THAT THERE WERE NO ISSUES OR DEVIATIONS DURING PRODUCTION AND QUALITY INSPECTION RESULTS WERE ACCEPTABLE. BASED ON ALL THE INFO PROVIDED TO US, WE BELIEVE ONE OF THE FOLLOWING THREE (3) EVENTS MAY HAVE OCCURRED: THE CAP WAS NOT SECURELY INSTALLED, AS OUR I.F.U. INDICATES IT MUST BE. THE PT REACHED UP AND DISLODGED THE CAP, IN WHICH CASE THE PT SHOULD HAVE BEEN RESTRAINED TO PREVENT THIS OR OTHER ISSUES, SUCH AS DISRUPTING AN I.V., O2 SUPPLY, ETC. BOTH EVENT 1 AND 2 OCCURRED CONCURRENTLY. WE HAVE DETERMINED NO CORRECTIVE ACTION IS WARRANTED FOR THE DEVICE OR THE I.F.U. WE REGARD THIS AS AN ISOLATED INCIDENCE OF A USER FAILING TO FOLLOW THE I.F.U. AND/OR SOUND R.T. PRACTICES.

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST AND A RN WITNESSED THAT THE "PROTECTIVE BLUE PIECE" AT THE END OF THE STIFF TIE ON THE BITE BLOCK HAD FALLEN OFF AND LANDED IN A PT'S MOUTH. RT SUPERVISOR CHECKED THE DEVICE AND FOUND THAT THE TIP DOES INDEED DISLODGE FAIRLY EASILY. HAD IT NOT BEEN FOR RT AND RN ATTENTION TO DETAIL, THAT PIECE COULD HAVE BEEN ASPIRATED BY THE PT WITH POTENTIALLY DISASTROUS CONSEQUENCES. THIS EVENT HAS OCCURRED ON MORE THAN ON OCCASION RESULTING IN NEAR ASPIRATION OF THE SMALL PART. DEVICE USAGE PROBLEM: OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40304 UNIVERSAL BITE BLOCK BITE BLOCK JXL B&B MEDICAL TECHNOLOGIES/INTEGRA BIOTECHNICAL, LLC. 11160 D224213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R