BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 4.5MM

    MDR report key: 6031591 · Received October 14, 2016

    Report

    Report Number
    9611594-2016-00135
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 23, 2016
    Report Date
    December 5, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    BTR
    PMA / PMN Number
    PK080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. THE DETACHED COMPONENT, A CUFF INFLATION LINE, WAS ALSO RETURNED WITH THE SAMPLE. A TERUMO 6ML SYRINGE WITH EFD TIP WAS USED TO ENERGIZE THE ET TUBE WITH AIR IN THE AREA WHERE THE ET TUBE AND CUFF INFLATION LINE SEPARATED. THE BALLOON CUFF INFLATED AND DEFLATED AS EXPECTED, WITH NO ISSUES OR BURST ON BOTH BONDED AREAS (PROXIMAL AND DISTAL) AND CUFF FABRIC. THE CONNECTION OF THE INFLATION LINE TO THE PILOT BALLOON WAS EXAMINED UNDER MAGNIFICATION (50X), AND NO DEFECT OR DAMAGE WAS SEEN AT THE POINT OF CONNECTION. THE POINT OF SEPARATION FOR THE TWO COMPONENTS (ET TUBE AND CUFF INFLATION LINE) APPEARED TO HAVE JAGGED EDGES AT THE BONDING JOINTS, AS IF THEY WERE TORN OR BITTEN. ROOT CAUSE WAS CONFIRMED TO BE UNRELATED TO THE MANUFACTURING PROCESS. 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 COMP-JHC-16-01601.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE ADDED MORE AIR TO THE CUFF ON THE 8TH DAY OF USE, BUT THE CUFF DID NOT RE-INFLATE AS NORMAL. DUE TO RISK OF LEAK, THE CUFF WAS CHANGED OUT FOR A NEW ONE, AND THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680607 ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 4.5MM KIMVENT MICROCUFF ET TUBES PEDIATRIC BTR HALYARD HEALTH 35114 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1