BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETY FLEX CUFFED

    MDR report key: 1101809 · Received August 6, 2008

    Report

    Report Number
    2936999-2008-00330
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    June 16, 2008
    Report Date
    July 11, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE SAFETYFLEX ENDOTRACHEAL TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MANUFACTURER WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE MANUFACTURER'S DIRECTIONS FOR USE STATES UNDER SUGGESTED DIRECTIONS FOR USE: REMOVE THE SYRINGE FROM THE VALVE HOUSING AFTER CUFF INFLATION. LEAVING THE SYRINGE ATTACHED WILL KEEP THE VALVE OPEN, PERMITTING THE CUFF TO DEFLATE. CHECK TO VERIFY THAT THE INFLATION SYSTEM IS NOT LEAKING. INTEGRITY OF THE SYSTEM SHOULD BE VERIFIED PERIODICALLY DURING THE INTUBATION PERIOD. CUFF PRESSURE SHOULD BE CLOSELY MONITORED AND ANY DEVIATION FROM THE SELECTED SEALING PRESSURE SHOULD BE INVESTIGATED AND CORRECTED IMMEDIATELY. NOTE: THE MANUFACTURER'S DIRECTIONS FOR USE STATES UNDER WARNING/PRECAUTIONS: VARIOUS BONY ANATOMICAL STRUCTURES (E.G. TEETH, TURBINATES) WITHIN THE INTUBATION ROUTE OR ANY INTUBATION TOOLS WITH SHARP SURFACES PRESENT A THREAT TO MAINTAINING CUFF INTEGRITY. CARE MUST BE TAKEN TO AVOID DAMAGING THE THIN WALLED CUFFS DURING INTUBATION WHICH CREATE THE NEED TO SUBJECT THE PT TO THE TRAUMA OF EXTUBATION AND RE-INTUBATION. IF THE CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED. SYRINGES, THREE WAY STOPCOCKS OR OTHER DEVICES SHOULD NOT BE LEFT INSERTED IN THE INFLATION VALVE FOR EXTENDED PERIODS OF TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT USE, THE INFLATION LINE WAS TORN AND LEAKAGE OCCURRED. THE PT WAS RE-INTUBATED. NO OTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY FLEX CUFFED REINFORCED ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO 2006096060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention