BEUDAMED
    FDA Adverse Event Other Summary report: N

    RUSCH

    MDR report key: 822587 · Received February 22, 2007

    Report

    Report Number
    8040412-2007-00002
    Event Type
    Other
    Date Received
    February 22, 2007
    Date of Event
    December 28, 2006
    Report Date
    February 22, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. VISUAL EXAMINATION. RESULTS: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSIONS: DEVICE FAILURE RELATED TO USER HANDLING. INVESTIGATION: THE DEVICE REPORTED IN THIS EVENT IS NOT SOLD IN THE USA, BUT A LIKE OR SIMILAR PRODUCT IS SOLD IN THE USA. THE REPORTED ISSUE WAS NOT CONFIRMED. CLOSE VISUAL EXAMINATION OF THE HOLE WITH HIGH MAGNIFICATION, SHOWED JAGGED EDGES. PART OF THE CUFF WALL APPEARED TO HAVE BEEN TORN OFF. THERE WERE NO SIGNS OF CREASES OR THINNING OF THE CUFF WALL AT THE TEAR AREA. THIS INDICATED THAT THE CUFF MATERIAL AT THE TEAR AREA HAD NOT BEEN STRETCHED OR DISTENDED BEFORE FAILURE. IT IS UNLIKELY THAT THE CUFF BURST. BASED ON THE APPEARANCE, IT IS QUITE LIKELY THAT THE CUFF HAD COME IN CONTACT WITH A SHARP OR POINTED OBJECT AND HAD TORN THE CUFF.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED ON 1/28/07 BY THE SALES MGR IN ANOTHER COUNTRY. THE FACILITY ALLEGES AN ENDOTRACHEAL TUBE HAD A HOLE IN THE CUFF WHICH CAUSED DESATURATION. THE PT HAD TO BE REINTUBATED. A PARTIAL CATALOG NUMBER, 112482 WITH A DESCRIPTION, ET TUBE 7.5MM, LOT NUMBER NUMBER 05JE40 WAS PROVIDED. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL UNK 05JE40

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention