BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZONAS POROUS TAPES

    MDR report key: 450565 · Received March 28, 2003

    Report

    Report Number
    2210968-2003-00119
    Event Type
    Injury
    Date Received
    March 28, 2003
    Date of Event
    February 26, 2003
    Report Date
    February 28, 2003
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (SHERMAN)
    Product Code
    KGX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WHO WAS INTUBATED AND VENTILATED WAS BEING TRANSFERRED FROM THE INTENSIVE CARE UNIT TO CT. IN THE PROCESS OF THE TRANSFER THE STAFF NOTICED THAT THE ENDOTRACHEAL TUBE HAD SLIPPED OUT OF THE TAPE. THE PATIENT ARRESTED AND WAS SUCCESSFULLY RESUSCITATED. THE TAPE WAS STILL IN PLACE PREVIOUSLY PLACED BY THE STAFF, BUT THE TUBE HAD SLIPPED COMPLETELY OUT. IN ADDITION, THE HOSPITAL REPORTS THAT THE TAPE HAD BEEN APPLIED TWELVE HOURS BEFORE THE REPORTED INCIDENT. THE TAPE HAD BEEN CHECKED LESS THAN TWO HOURS BEFORE THE REPORTED INCIDENT. THE PATIENT WAS IMMEDIATELY RETURNED TO THE INTENSIVE CARE UNIT AND REINTUBATED. THE TUBE WAS A 5.0 UNCUFFED ORAL ENDOTRACHEAL TUBE. THE TAPE HAD BEEN APPLIED AS PER THE STANDARD PROTOCOL. THERE WERE TWO PIECES OF TAPE CUT IN A "V" HALF WAY ALONG THE LENGTH OF THE TAPE. THE FULL PIECE OF THE TAPE WAS ON THE CHEEK AND THE OTHER PART OF THE TAPE WAS SPLIT IN TWO PIECES ("V"). THE TOP PIECE OF THE "V" GOES BELOW THE NOSE, ALONG THE LIP, AND IS ANCHORED AND SECURED ON THE OTHER PIECE OF TAPE ON THE OTHER CHEEK. THE BOTTOM PIECE OF THE "V" TAPE IS ANCHORED TO THE SKIN UNTIL IT IS WRAPPED AROUND THE ENDOTRACHEAL TUBE AT LEAST TWICE, AND THE REMAINING TAPE IS ANCHORED BETWEEN THE LIP AND THE NOSE. THE WHOLE PROCESS IS COMPLETED AGAIN ON THE OTHER SIDE OF THE FACE. ONE SINGLE PIECE OF WATERPROOF TAPE IS PLACED OVER ALL OF THE WHITE TAPE ON THE FACE FOR WATERPROOFING PURPOSES, AND SERVES NO SECURING FUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZONAS POROUS TAPES ADHESIVE TAPE AND BANDAGE KGX JOHNSON & JOHNSON MEDICAL (SHERMAN) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention