BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M PICC/CVC SECUREMENT DEVICE

    MDR report key: 3800235 · Received April 30, 2014

    Report

    Report Number
    2110898-2014-00022
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 18, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    KMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT PROVIDED TO MANUFACTURER FOR EVALUATION. COMPLAINT TYPE IS BEING MONITORED AND ANALYZED.

    Description of Event or Problem · 1

    NURSE REPORTED PATIENT WAS RECEIVING ANTIBIOTICS THROUGH PICC CATHETER. 1839-2100 PICC/CVC DEVICE + TEGADERM IV ADVANCED DRESSING SECURED AND COVERED THE SITE. AT REMOVAL, NURSE ALLEGED THE SKIN WAS RED, BLISTERY AND SEEPING UNDER THE DRESSING. REPORTED TEGADERM DRESSING WAS DISCONTINUED AND REPLACED WITH GAUZE DRESSING. REPORTED PICC WAS EVENTUALLY DISCONTINUED DUE TOT SKIN CONDITION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258956 3M PICC/CVC SECUREMENT DEVICE DEVICE, INTRAVASCULAR CATHETER SECUR KMK 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention