BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEONATAL/PEDIATRIC ENDOTRACHEAL TUBE HOLDER FOR TUBES

    MDR report key: 2999588 · Received March 6, 2013

    Report

    Report Number
    MW5029283
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SMITHS MEDICAL INC
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT USED: SMITHS MEDICAL TUBE HOLDER, SIZE 3.0, CAT # H4052 TO SECURE THE BABIES ENDOTRACHEAL TUBE CAME APART AND ULTIMATELY EXTUBATED THE BABY WHILE IT WAS BEING MECHANICALLY VENTILATED. THE PART THAT SECURES THE TUBE TO THE ADHESIVE CAME OFF AND WAS FOUND LYING ON THE BABIES BED. THE ADHESIVE WAS STILL IN PLACE ON THE BABIES FACE. THE BABY DID NOT EXPERIENCE AN ADVERSE EFFECT, AND WAS TREATED QUICKLY WITH OXYGEN AND ANOTHER OXYGEN DEVICE, BUT SERIOUS PRODUCT CONCERNS REMAIN. IT WAS IN PLACE FOR A TOTAL OF 25.5 HRS. DATES OF USE: (B)(6) 2013 - (B)(6) 2013, 25 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95229 NEONATAL/PEDIATRIC ENDOTRACHEAL TUBE HOLDER FOR TUBES TUBE HOLDER SIZE 3.0 BTR SMITHS MEDICAL INC H4052 2322827

    Patients

    Seq Age Sex Outcome Treatment
    1 51 DA Life Threatening NEONATAL/PEDIATRIC ENDOTRACHEAL TUBE HOLDER FOR| (B)(6) 2013 AT 1850.| TUBES 3.0MM ID H4052. TUBE HOLDER PLACED ON| (B)(6) 2013 AT 1715 AND MALFUNCTIONED ON