BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM IV ADVANCED SECUREMENT DRESSING

    MDR report key: 2973502 · Received February 15, 2013

    Report

    Report Number
    2110898-2013-00004
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 5, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    KMK
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE NOT RETURNED NO EVALUATION CAN BE PERFORMED. DEVICE NOT PROVIDED TO MANUFACTURER FOR EVALUATION. (B)(4). PRECAUTIONS: STOP ANY BLEEDING AT THE SITE BEFORE APPLYING THE DRESSING. DO NOT STRETCH THE DRESSING DURING APPLICATION AS TENSION CAN CAUSE SKIN TRAUMA. MAKE SURE THE SKIN IS CLEAN, FREE OF SOAP RESIDUE AND LOTION AND ALLOWED TO DRY THOROUGHLY BEFORE APPLYING THE DRESSING TO PREVENT SKIN IRRITATION AND TO ENSURE GOOD ADHESIONS. THE DRESSING MAY BE USED ON AN INFECTED SITE, ONLY WHEN UNDER THE CARE OF A HEALTH CARE PROFESSIONAL. ANTIMICROBIAL OINTMENTS CONTAINING POLYETHYLENE GLYCOLS MAY COMPROMISE THE STRENGTH OF THE TEGADERM I. V. ADVANCED SECUREMENT DRESSING. TEGADERM I.V. ADVANCED SECUREMENT DRESSING SHOULD NOT BE RE-STERILIZED BY GAME, E-BEAM OR STEAM METHODS.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES PATIENT DEVELOPED SKIN IRRITATION FOLLOWING USE OF PICC/CVC SECUREMENT SYSTEM (B)(4) ON A PICC CATHETER SITE. CUSTOMER REPORTS PATIENT DEVELOPED FEVER SO PICC CATHETER REMOVED AND CULTURED. CUSTOMER REPORTS NEGATIVE CATHETER CULTURE RESULTS AND PICC CATHETER WAS REPLACED. CUSTOMER REPORTS NO PREVIOUS PATIENT HISTORY OF SKIN IRRITATION FROM ADHESIVE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69700 TEGADERM IV ADVANCED SECUREMENT DRESSING DEVICE, INTRAVASCULAR CATHETER SECUREMENT KMK 3M HEALTH CARE 1837 2012-12 AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BETADINE| ALCOHOL| SILVASORB ANTIMICROBIAL DRESSING| CATHETER