BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M TEGADERM I.V. ADVANCED SECUREMENT DRESSING

    MDR report key: 6901463 · Received September 28, 2017

    Report

    Report Number
    2110898-2017-00133
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 16, 2017
    Report Date
    September 28, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER HAS BEEN RECEIVED FOR THIS REPORT. THIS CUSTOMER REPORTED THEY HAVE BEEN EXPERIENCING SPORADIC LOW ADHESION WITH 1683 TEGADERM IV ADVANCED SECUREMENT DRESSINGS. REPORT #2110898-2017-00112 WAS SENT TO THE FDA. IN THE INITIAL REPORT, THE CUSTOMER PROVIDED POTENTIAL LOT NUMBERS FOR INVESTIGATION BY 3M. MFR 3M QUALITY ENGINEER INVESTIGATED THOSE LOT NUMBERS AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR ANY OF THE LOT NUMBERS PROVIDED. FOR THE FIRST REPORTED EVENT, THE CUSTOMER ALSO SENT SAMPLES FROM THEIR STOCK FOR EVALUATION. THE SAMPLES WERE TESTED AND THE CARRIER, BORDER AND FILM ADHESION WERE CONSISTENT WITH OUR PRODUCT DATA FOR ETO STERILIZED KITS WHICH WOULD BE PROCESSED THROUGH OEM KIT MANUFACTURERS. THE CUSTOMER PROVIDED ADDITIONAL INFORMATION REGARDING A SPECIFIC INFANT WHO EXPERIENCED LOSS AND SUBSEQUENT REPLACEMENT OF THEIR PICC CATHETER ON TWO DIFFERENT DATES. THE INFANT WAS REPORTED AS BEING VERY ACTIVE AND DIAPHORETIC. REPORT NUMBERS 2110898-2017-00132 AND 2110898-2017-00133 WERE SENT TO THE FDA TODAY TO CAPTURE THESE REPORTED EVENTS. THE CUSTOMER DID NOT ACCEPT OFFERS FOR A SITE VISIT FROM A 3M CLINICAL REPRESENTATIVE FOR ASSESSMENT AND DISCUSSION OF PRODUCT APPLICATION AND FACILITY PROTOCOL.

    Description of Event or Problem · 1

    A NURSE REPORTED A FEMALE INFANT EXPERIENCED DISLODGEMENT OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WHEN A 1683 TEGADERM IV ADVANCED SECUREMENT DRESSING WAS USED FOR SECUREMENT. THE PATIENT REQUIRED A NEW PICC LINE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682233 3M TEGADERM I.V. ADVANCED SECUREMENT DRESSING TEGADERM I.V. ADVANCED SECUREMENT DRESSING KMK 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention