BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1132585 · Received August 22, 2008

    Report

    Report Number
    2936999-2008-00400
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS DISCARDED AND THEREFORE UNAVAILABLE FOR FAILURE INVESTIGATION. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. THE LOT NUMBER WAS PROVIDED AND THE MANUFACTURER WILL REVIEW THE LOT HISTORY RECORDS. IF THE REVIEW FINDS NEW OR SIGNIFICANT INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE MANUFACTURER'S DIRECTIONS FOR USE STATES UNDER INSTRUCTIONS FOR USE: CUFFED MODELS (LPC, FEN) HAVE A THIN WALL, HIGH VOLUME, LOW PRESSURE CUFF TO MINIMIZE PRESSURE IN THE TRACHEA. WHEN INFLATED, THE CUFF CONFORMS TO THE NATURAL SHAPE OF THE TRACHEA PROVIDING A SEAL AT LOW INTRACUFF PRESSURE. THE CUFF INFLATION LINE HAS A LUER VALVE WITH AN INTEGRAL PILOT BALLOON TO INDICATE CUFF INFLATION. NOTE: THE MANUFACTURE'S DIRECTIONS FOR USE STATES UNDER TUBE PREPARATION: SELECTION OF THE TRACHEOSTOMY TUBE SIZE IS LEFT TO THE DISCRETION OF THE PHYSICIAN. PATIENTS IN THE HOME CARE ENVIRONMENT SHOULD BE CAREFULLY INSTRUCTED BY THEIR HOME HEALTH CARE PROVIDER IN THE PROPER USE AND HANDLING OF THIS DEVICE. NOTE: THE MANUFACTURE'S DIRECTIONS FOR USE STATES UNDER PRE-INSERTION CUFF AND INFLATION TEST: NOTE: REFER TO TABLE 1 FOR LEAK TEST INFLATION VOLUMES. INFLATION VOLUMES ARE FOR TEST PURPOSES ONLY. CONSULT THE PHYSICIAN OR HOME HEALTH CARE PROVIDER FOR THE APPROPRIATE INFLATION VOLUME/PRESSURE WHEN THE TUBE IS POSITIONED WITHIN THE TRACHEA. WITH SHILEY CUFFED MODELS (LPC, FEN) THE CUFF AND INFLATION SYSTEM SHOULD BE TESTED FOR LEAKAGE BEFORE INSERTING THE TUBE. THIS TEST CAN BE PERFORMED AS FOLLOWS: INFLATE THE CUFF WITH THE VOLUME OF AIR INDICATED IN TABLE 1. THEN EITHER OBSERVE FOR DEFLATION OVER SEVERAL MINUTES OR IMMERSE THE TUBE IN STERILE SALINE AND OBSERVE FOR AIR LEAKAGE. DEFLATE THE CUFF PRIOR TO INSERTION. NOTE: THE MANUFACTURE'S DIRECTIONS FOR USE STATES UNDER INSERTION: CAUTION: TO EASE INSERTION AND TO GUARD AGAINST CUFF PERFORATION FROM SHARP EDGES OF CARTILAGE, THE CUFF SHOULD BE TAPERED BACK. THIS CAN BE ACCOMPLISHED BY FIRST INFLATING THE CUFF. THEN GENTLY MOVE THE CUFF AWAY FROM THE DISTAL TIP OF THE OUTER CANNULA TOWARDS THE SWIVEL NECK PLATE AS THE RESIDUAL AIR IS REMOVED BY DEFLATION. DO NOT USE ANY SHARP INSTRUMENTS SUCH AS FORCEPS OR HEMOSTATS THAT WOULD DAMAGE THE CUFF WHEN TAPERING IT. NOTE: THE MANUFACTURE'S DIRECTIONS FOR USE STATES UNDER CUFF INFLATION: WARNINGS: UNDER NO CIRCUMSTANCES SHOULD MORE THAN 25 MM OF MERCURY AIR PRESSURE BE USED TO INFLATE THE CUFF. OVER-INFLATION OF THE CUFF MAY CAUSE TRACHEAL DAMAGE AND MAY INHIBIT VENTILATION. AS A FURTHER PRECAUTION FOR VENTILATOR-DEPENDENT PATIENTS, CUFF INFLATION SHOULD BE CHECKED ON A REGULAR BASIS AND REPLACEMENT TRACHEOSTOMY TUBES SHOULD BE KEPT AT BEDSIDE. INFLATE THE LOW PRESSURE CUFF BY INJECTING AIR INTO THE LUER VALVE OF THE INFLATION LINE USING A SYRINGE. SELECTION OF A CUFF INFLATION AND DEFLATION PROCEDURE IS LEFT TO THE DISCRETION OF THE PHYSICIAN.

    Description of Event or Problem · 1

    THE O.R. SUPERVISOR STATED THAT THE PATIENT'S DOCTOR CALLED THE O.R. FOR AN 8 LOW PRESSURE CUFFED TRACHEOSTOMY TUBE TO BE PLACED IN THE PATIENT. THE PATIENT ALREADY HAD A TRACHEOSTOMY TUBE IN PLACE AND THE DOCTOR WAS REPLACING IT. THE PATIENT IS A MALE. THE SUPERVISOR DID NOT KNOW IF THE CUFFS WERE PRETESTED. THE FIRST TRACHEOSTOMY TUBE WAS PLACED IN THE PATIENT AND INFLATED, AND WITHIN SEVERAL HOURS NEEDED TO BE REPLACED DUE TO LEAKING. THE SECOND TRACHEOTOMY TUBE WAS PLACED IN THE PATIENT AND ALSO LEAKED SEVERAL HOURS LATER. THE DOCTOR REMOVED SECOND TRACHEOSTOMY TUBE IN THE PATIENT WITH NO INCIDENT. NEITHER 8 LOW PRESSURE CUFFED TRACHEOSTOMY TUBES ARE AVAILABLE FOR ANALYSIS AND WERE THROWN OUT. THE FIRST 8 LOW PRESSURE CUFFED TRACHEOSTOMY TUBE IS BEING REPORTED ON 2936999-2008-00399.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCO HEALTHCARE 0801001899

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention