BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M MULTIPORE DRY TAPE

    MDR report key: 6545810 · Received May 4, 2017

    Report

    Report Number
    2110898-2017-00067
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    March 24, 2017
    Report Date
    March 29, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFANT WAS REPORTED TO BE (B)(6) GESTATION AND (B)(6), LESS THAN (B)(6). LOT NUMBER WAS NOT PROVIDED BY THE REPORTER. WITHOUT A LOT NUMBER, IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURER DATE OR EXPIRATION DATE. CUSTOMER REPORTED THE TAPE WAS APPLIED ON (B)(6) 2017 AND NOTED TO BE UNRAVELLING ON (B)(6) 2017. THE FACILITY DOES NOT CURRENTLY HAVE A POLICY FOR RE-TAPING. CUSTOMER REPORTED SHE FELT THIS INCIDENT WAS PREVENTABLE WITH CLOSER ASSESSMENT TO ENSURE THE ETT IS RE-TAPED WHEN NECESSARY. 3M RECOMMENDS CLINICIANS MONITOR TAPE ADHESION PERIODICALLY. 3M RECOMMENDS THE TAPE BE REPLACED IF IT BECOMES OVERLY SATURATED, LOOSE OR SOILED. FULL RECOMMENDATIONS TO MAXIMIZE ADHESION FOR MULTIPORE DRY TAPE ARE LISTED BELOW. 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:GO.3M.COM/CTS APPLICATIONS PLEASE WORK WITH YOUR LOCAL SALES REPRESENTATIVE FOR ADDITIONAL TRAINING AS NEEDED. 3M PROFESSIONAL SERVICE SPECIALIST CONTACTED THE CUSTOMER FOR DISCUSSION OF THE REPORTED EVENT AND OFFERED INSERVICING AND TROUBLESHOOTING. THE INSERVICING WAS NOT ACCEPTED AT THIS TIME. THE CUSTOMER REPORTED THEY WERE CURRENTLY DOING AN INTENSIVE PROJECT TO DECREASE NUMBER OF UNPLANNED EXTUBATIONS WHICH INCORPORATES MANY VARIABLES, TAPING BEING ONE OF THEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 3730-0 MULTIPORE DRY TAPE WAS USED TO SECURE AN INFANT'S ORAL GASTRIC (OG) AND ENDOTRACHEAL TUBE (ETT). WHILE THE INFANT WAS BEING HELD BY THE MOTHER, THE TAPE REPORTEDLY LOOSENED FROM THE NEOBAR. THE TAPE WAS REPORTEDLY STILL ATTACHED TO THE ETT. THE ETT WAS REPORTEDLY SUPPORTED BY THE NURSE AND THE INFANT WAS TRANSFERRED BACK TO THE BED. DURING TRANSFER, THE ETT REPORTEDLY MIGRATED OUT OF POSITION AND THE INFANT EXPERIENCED AN UNPLANNED EXTUBATION. THE INFANT WAS REINTUBATED ON FIRST ATTEMPT AND REPORTEDLY DID NOT SUFFER ANY FURTHER CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327213 3M MULTIPORE DRY TAPE MULTIPORE DRY TAPE KGX 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention ENDOTRACHEAL TUBE| NEOBAR