BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER MEDICAL FLEX-TIP PREFORMED ORAL CUFFED TRACHEAL TUBE

    MDR report key: 3177958 · Received June 12, 2013

    Report

    Report Number
    MW5030593
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 5, 2013
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER INDUCTION OF GENERAL ANESTHESIA, I ATTEMPTED TO INTUBATE THE TRACHEA WITH A 5.5 CUFFED ORAL PRE-FORMED ("RAE") PARKER FLEX-TIP ENDOTRACHEAL TUBE (PARKER MEDICAL, PART PFOC). THE CUFF OF THIS TUBE IS MANUFACTURED OUT OF A VERY THICK AND NON-COMPLIANT VINYL LIKE MATERIAL, AND WHEN FULLY DEFLATED, IT FORMS A NEARLY RIGID AND SHARP-EDGED RIDGE THAT IS OVER TWICE THE DIAMETER OF THE ENDOTRACHEAL TUBE ITSELF. IT WAS IMPOSSIBLE TO PASS THE TUBE THROUGH THE VOCAL FOLDS- I WAS AFRAID OF CAUSING DAMAGE, AND HAD TO VENTILATE BY BAG AND MASK UNTIL OUR TECH WAS ABLE TO FIND A TUBE FROM ANOTHER MANUFACTURER. THIS IS THE SECOND ADVERSE EVENT I HAVE HAD WITH THESE TUBES- THE FIRST TIME (IN A (B)(6) CHILD) THE TUBE PASSED, WITH SOME RESISTANCE, THROUGH THE CORDS, BUT WHEN THE CASE WAS OVER AND THE CUFF WAS FULLY DEFLATED, IT WAS EXTREMELY DIFFICULT TO REMOVE THE TUBE, BECAUSE OF THE SAME REASON DESCRIBED ABOVE. IN THIS CASE, THE RIDGE OF DEFLATED CUFF HUNG UP IN THE SUBGLOTTIS. I WAS ABLE TO REMOVE THE TUBE WITH SOME DIFFICULTY AND (LUCKILY) WITHOUT INJURY TO THE PATIENT. THE CUFF DESIGN ON THIS TUBE IS POTENTIALLY DANGEROUS. THE PROBLEMS ARE (1) CUFF MATERIAL THAT IS POORLY SUITED FOR ITS FUNCTION - TOO THICK AND INFLEXIBLE (2) A CUFF THAT IS TOO VOLUMINOUS AND (3) A CUFF THAT HAS EXCESSIVE LENGTH. THE PRE-FORMED ORAL AND NASAL TUBES (BOTH CUFFED AND UNCUFFED) HAVE ALSO CAUSED OTHER PROBLEMS AT OUR HOSPITAL BECAUSE THE BEND IN THE TUBE IS NOT IN THE PROPER PLACE. WE HAVE HAD MANY INSTANCES OF INADVERTENT ENDOBRONCHIAL INTUBATION BECAUSE THE BEND OF THE TUBE IS TOO FAR FROM THE TIP, RESULTING IN MALPOSITION WHEN INSERTED TO THE DEPTH THAT RESULTS FROM PROPER PLACEMENT OF THE BEND AT THE LIP OR NARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265326 PARKER MEDICAL FLEX-TIP PREFORMED ORAL CUFFED TRACHEAL TUBE ENDOTRACHEAL TUBE BTR PARKER MEDICAL PFOC

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention