BEUDAMED
    FDA Adverse Event Other Summary report: N

    B&B MEDICAL TECHNOLOGIES

    MDR report key: 2629773 · Received May 15, 2012

    Report

    Report Number
    2938401-2012-00001
    Event Type
    Other
    Date Received
    May 15, 2012
    Date of Event
    April 18, 2012
    Report Date
    May 9, 2012
    Manufacturer
    B&B MEDICAL TECHNOLOGIES, INC. / INTEGRA BIOTECHNICAL, LLC
    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 TO BE RETURNED AND EVALUATED. EACH BITE PROOF BITE BLOCK IS PACKAGED WITH INSTRUCTIONS FOR USE. INSTRUCTED IN THE INSTRUCTIONS FOR USE IS A CAUTION NOTICE THAT STATES: "SHOULD CUFF FILLING PROBLEM OCCUR, GENTILE PULL THE PILOT BALLOON TUBE TAUT TO REMOVE ANY KINKS."

    Description of Event or Problem · 1

    ON (B)(4) 2012, B&B MEDICAL TECHNOLOGIES WAS CONTACTED BY (B)(6) OF MEDICAL CENTER TO REPORT THAT THERE HAD BEEN AN INCIDENT ON (B)(6) 2012, INVOLVING THE B&B BITE PROOF BITE BLOCK PART NUMBER 11040 LOT# D133437. WHAT OCCURRED ON (B)(6) 2012 WAS THAT THE MEDICAL STAFF WAS NOT ABLE TO INFLATE THE PILOT BALLOON (CUFF) OF A MALLINCKRODT TAPERGUARD EVAC ORAL TRACHEAL TUBE WHILE IN USE ON A PT WITH A B&B BITE PROOF BITE BLOCK. THE ET TUBE WAS REMOVED AND THE PT WAS RE-INTUBATED. AFTER EXAMINING THE INITIAL ET TUBE, IT WAS DISCOVERED THAT THERE WAS A KINK IN THE PILOT TUBING. IT IS UNCLEAR IF KINKED TUBE HAD SIGNIFICANT EFFECT ON PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other