BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M MULTIPORE DRY TAPE

    MDR report key: 6443170 · Received March 29, 2017

    Report

    Report Number
    2110898-2017-00041
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    February 1, 2017
    Report Date
    March 21, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER DID NOT HAVE INDIVIDUAL PATIENT INFORMATION. (B)(6) 2017 WAS USED AS THE DATE OF THE EVENT. REPORTER DID NOT HAVE THE EXACT DATE OF THE EVENT BUT STATED THE TAPE WAS USED IN (B)(6) 2017 DURING A PRODUCT EVALUATION. LOT NUMBER WAS NOT PROVIDED BY THE REPORTER. WITHOUT A LOT NUMBER, IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURER DATE OR EXPIRATION DATE. NO DEVICE HAS BEEN RECEIVED FOR EVALUATION AS OF THE DATE OF THIS REPORT. CUSTOMER REPORTED THEY USED 3730-1 MULIPORE TAPE TO SECURE INFANT'S ENDOTRACHEAL TUBES AND ALLEGED FOUR UNPLANNED EXTUBATIONS OCCURRED. FOUR INDIVIDUAL MDR REPORTS WERE FILED WITH THE FDA (2110898-2017-00041, 2110898-2017-00042, 2110898-2017-00043, 2110898-2017-00044). CUSTOMER REPORTED THE TAPE THEY HAD BEEN USING WAS BEING DISCONTINUED SO THEY ORDERED 3M MULIPORE TAPE AND STARTED AN EVALUATION. A 3M ACCOUNT REPRESENTATIVE WAS UNAWARE OF THE EVALUATION AND DID NOT PROVIDE TRAINING BEFORE USE. 3M TECHNICAL SERVICES SPECIALIST CONTACTED THE CUSTOMER AND PROVIDED APPLICATION/REMOVAL INSTRUCTIONS AND ALSO CONTACTED THE LOCAL 3M SALES REPRESENTATIVE FOR FOLLOW-UP WITH THE FACILITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 3730- 1 MULTIPORE DRY TAPE WAS USED TO SECURE AN INFANT'S ENDOTRACHEAL TUBE(ETT). CUSTOMER ALLEGED THE ETT SLIPPED THROUGH THE TAPE RESULTING IN AN UNPLANNED EXTUBATION. THE INFANT REPORTEDLY REQUIRED REINTUBATION. CUSTOMER REPORTED THERE WAS NO KNOWN PATIENT HARM OR INJURY AS A RESULT OF THE UNPLANNED EXTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225383 3M MULTIPORE DRY TAPE MULTIPORE DRY TAPE KGX 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENDOTRACHEAL TUBE