BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE ALUMINIUM STYLETTE

    MDR report key: 1725403 · Received June 10, 2010

    Report

    Report Number
    3006389770-2010-00004
    Event Type
    Other
    Date Received
    June 10, 2010
    Date of Event
    December 14, 2009
    Report Date
    May 14, 2010
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST COMPLAINT RECEIVED FOR THE STYLET SINCE THE PRODUCT WAS MADE FOR (B)(4) SINCE (B)(4) 2006. AFTER RECEIPT OF THIS, A STUDY WAS CONDUCTED AS TO WHEN THE ALUMINIUM STYLET COULD CRACK. THE STYLET COULD CRACK AT A POINT, IF THE STYLET IS HELD STEADY AT THAT POINT AND BENT BACK AND FORTH THROUGH AN ANGLE OF 150 - 160 DEGREES 3-4 TIMES. SUCH A BENDING EXERCISE IS/WAS NOT ANTICIPATED FOR AN INTUBATION. AFTER THIS EVENT, WE HAVE ALREADY WORKED OUT TO MODIFY THE PROPERTIES OF THE STYLET TO LAST 7-8 BENDS AT THE SAME POINT BEFORE CRACKING. ALSO AN INSTRUCTION WILL BE PUT ON THE PACKAGE ABOUT THIS IN FUTURE LOTS.

    Description of Event or Problem · 1

    SINGLE USE ALUMINIUM STYLETTE WAS USED DURING DIFFICULT INTUBATION ON A MORBIDLY OBESE PATIENT. THE INTUBATION GUIDE (STYLETTE) WAS MANOEUVERED WHILE INSERTED INTO THE ENDOTRACHEAL TUBE, THE DISTAL END BROKE OFF INSIDE THE TUBE, SLID THROUGH THE TUBE AND WENT INTO THE PATIENT'S TRACHEA. FIBROBRONCHOSCOPY WAS PERFORMED IN ORDER TO REMOVE THE REMAINING PART FROM THE PATIENT. NO INFECTION RESULTED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE ALUMINIUM STYLETTE STYLETTE BSR MEDITEC DEVICES 9-0204-25 MD011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention