BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M MULTIPORE DRY TAPE

    MDR report key: 6888560 · Received September 22, 2017

    Report

    Report Number
    2110898-2017-00123
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    August 22, 2017
    Report Date
    September 22, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS NOT PROVIDED BY THE REPORTER. WITHOUT A LOT NUMBER, IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURER DATE OR EXPIRATION DATE. THE CUSTOMER REPORTED THEY HAVE ALSO BEEN USING THE PRODUCT FOR ENDOTRACHEAL TUBE SECUREMENT IN THEIR PEDIATRIC ICU AND HAVE NOT HAD ANY REPORTED ISSUES. A 3M REPRESENTATIVE PROVIDED PRODUCT RE-TRAINING. THE FACILITY FOUND THE TRAINING VALUABLE AND CONTINUE TO USE THE PRODUCT. TO MAXIMIZE ADHESION OF MULTIPORETM DRY SURGICAL TAPE FOR TUBING SECUREMENT, THE FOLLOWING APPLICATION TECHNIQUES ARE RECOMMENDED: APPLY 3M¿ CAVILON¿ NO STING BARRIER FILM TO PROTECT AT-RISK SKIN. ALLOW TO DRY COMPLETELY BEFORE APPLYING TAPE. (WITH FOLLOWING DISCLAIMER) *3M¿ CAVILON¿ NO STING BARRIER FILM MAY BE APPLIED TO ADULTS, CHILDREN AND INFANTS OVER 1 MONTH OF AGE. CAVILON NO STING BARRIER FILM IS NOT RECOMMENDED FOR INFANTS UNDER 1 MONTH OF AGE. APPLY TAPE TO CLEAN, DRY SKIN AND DEVICES. APPLY TAPE WITH SOME TENSION TO REDUCE GAPS AND LOOSENESS, BUT DO NOT OVERSTRETCH THE TAPE TO DEVICES AND SKIN. AFTER APPLICATION USE FIRM PRESSURE TO MAXIMIZE ADHESION TO TUBE AND/OR SKIN. IF POSSIBLE, SPIRAL THE TAPE AROUND THE TUBING TO MAXIMIZE SURFACE AREA OF ADHESIVE TO TUBING. MONITOR TAPE ADHESION PERIODICALLY. IT IS RECOMMENDED TAPE BE REPLACED IF IT BECOMES OVERLY SATURATED, LOOSE OR SOILED. ACCESS THE FOLLOWING LINK FOR ADDITIONAL TRAINING VIDEOS: (B)(4). PLEASE WORK WITH YOUR LOCAL SALES REPRESENTATIVE FOR ADDITIONAL TRAINING AS NEEDED.

    Description of Event or Problem · 1

    A RESPIRATORY THERAPIST REPORTED A NEONATE EXPERIENCED AN UNPLANNED EXTUBATION WHEN THEIR ENDOTRACHEAL TUBE WAS SECURED WITH 3730-0 MULTIPORE DRY TAPE. THE NEONATE WAS REINTUBATED AND DID NOT EXPERIENCE ANY KNOWN ADVERSE CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666751 3M MULTIPORE DRY TAPE MULTIPORE DRY TAPE KGX 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 WK Required Intervention