BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M MULTIPORE DRY TAPE

    MDR report key: 6356596 · Received February 24, 2017

    Report

    Report Number
    2110898-2017-00024
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    February 20, 2017
    Report Date
    April 3, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) TECHNICAL SERVICE SPECIALIST HAS SCHEDULED FOLLOW-UP WITH THE FACILITY TO PROVIDE PRODUCT EDUCATION.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS RECEIVED AND SENT TO MANUFACTURING FOR TESTING. TEST SAMPLES MET 3M SPECIFICATIONS FOR ADHESION TO TUBING. A 3M REPRESENTATIVES FOLLOWED UP WITH THE FACILITY AND PROVIDED THE FOLLOWING INFORMATION: TO MAXIMIZE ADHESION OF MULTIPORE TM 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:GO.3M.COM/CTSAPPLICATIONS. PLEASE WORK WITH YOUR LOCAL SALES REPRESENTATIVE FOR ADDITIONAL TRAINING AS NEEDED.

    Description of Event or Problem · 1

    A NURSE REPORTED 3730-1 MULTIPORE DRY TAPE WAS USED TO SECURE A FEMALE INFANT'S ENDTRACHEAL TUBE (ETT). THE INFANT REPORTEDLY STARTED TO DESATURATE AND THE NURSE NOTED THE ETT HAD SLIPPED THROUGH THE TAPE. THE TAPE HAD BEEN APPLIED FOR 10 HOURS WHEN THE INCIDENT OCCURRED. THE INFANT REQUIRED REINTUBATION, WAS REPORTEDLY DOING WELL, AND DID NOT SUFFER ANY KNOWN CONSEQUENCES DUE TO THE ACCIDENTAL EXTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140114 3M MULTIPORE DRY TAPE MULTIPORE DRY TAPE KGX 3M HEALTH CARE 2018-08 AD

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention ENDOTRACHEAL TUBE