BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD MICROCUFF SUBGLOTTIC ET TUBES SAP LEVEL 7

    MDR report key: 5750462 · Received June 27, 2016

    Report

    Report Number
    9611594-2016-00097
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    June 15, 2016
    Report Date
    August 4, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    BTR
    PMA / PMN Number
    PK131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HE SAMPLE WAS RECEIVED AND EVALUATED. ONE USED SAMPLE WAS RECEIVED WITH NO PACKAGING. THE PRODUCT DOES NOT CONTAIN A LOT NUMBER IDENTIFICATION. THE INTERIOR OF THE ET TUBE IS COATED WITH BROWN BIOLOGIC MATTER. THIS IS ADHERED TO THE INNER WALL OF THE TUBE AND DID NOT FLUSH OUT DURING DECONTAMINATION. THE CUFF WAS INFLATED WITH AIR USING A 6ML MONOJECT LUER TIP SYRINGE. IMMEDIATELY UPON INFLATION, A SLOW LEAKAGE OCCURRED. THE INFLATED CUFF WAS SUBMERGED IN WATER TO OBTAIN A VISUAL INDICATION OF THE LEAK LOCATION. THE LEAK WAS SEEN TO OCCUR AT THE PROXIMAL CUFF SHOULDER AREA. FOR POINT OF REFERENCE, THE LEAK IS OFFSET FROM THE WHITE RADIOPAQUE LINE. AN ATTEMPT WAS MADE TO SEE THE HOLE UNDER MAGNIFICATION. IT WAS NOT POSSIBLE TO GET A VISUAL ON THE HOLE AS THE CUFF MATERIAL WAS COLLAPSING AND FOLDING IN ON ITSELF AS DEFLATION OCCURRED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, AA5145V01, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). : DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AND ENDOTRACHEAL TUBE HAD VENT ALARMS TO GO OFF AND LOST CUFF PRESSURE. THE CUFF COULD NOT BE RE-INFLATED AND THE PATIENT HAD TO BE RE-INTUBATED. THERE WAS NO OTHER MEDICAL INTERVENTION WITH THIS PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408063 HALYARD MICROCUFF SUBGLOTTIC ET TUBES SAP LEVEL 7 VAP MICROCUFF ENDOTRACHEAL TUBES BTR HALYARD HEALTH 13221 AA5145V01

    Patients

    Seq Age Sex Outcome Treatment
    1