BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M TEGADERM CHG PORT DRESSING

    MDR report key: 7641119 · Received June 26, 2018

    Report

    Report Number
    MW5078083
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    June 20, 2018
    Report Date
    June 22, 2018
    Manufacturer
    3M COMPANY, 3M HEALTHCARE
    Product Code
    NAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCESSED PORT ON PEDIATRIC PATIENT USING THE NEW TEGADERM CHG 3M DRESSING. PORT WAS ACCESSED AND DRESSING APPLIED AS TRAINED WITHOUT COMPLICATIONS. PT MEDICATION STARTED AND WAS INFUSING VIA PORT. STEPPED AWAY FROM BEDSIDE TO PREPARE NEXT MEDICATION. FLOOR MA ENTERED THE MED ROOM AND STATED THAT THE PATIENT'S PORT NEEDLE WAS OUT, AS MOM REPORTED. WENT TO THE BS AND NEEDLE WAS OUT FROM PORT INJECTION SITE UNDER 3M NON-ADHESIVE PORTION OF THE 3M DRESSING. NEEDLE LAYING AGAINST PT'S CHEST. QUICKLY REMOVED DRESSING, ASSESSED SITE. PT DOES HAVE 3 RED ROUND MARKS THAT APPEAR TO BE FROM NEEDLE POKING THE SKIN UNDER THE NON-ADHESIVE PORTION. CALLED PROVIDER AND UPDATED ON EVENTS. NEW ORDER FOR MEDICATION WAS NEEDED, BECAUSE THE MEDICATION DID NOT INFUSE AS NEEDLE WAS DISLODGED. PORT SITE RE-ACCESSED USING STERILE TECHNIQUE. DRESSING APPLIED WAS NOT THE CHG DRESSING. DRESSING APPLIED WAS 3M ADHESIVE TEGADERM FILM (1624W). THE DETAILS IN THE REPORT IS THE EXTENT TO WHICH WE IDENTIFY MEDICATIONS INVOLVED OR PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479396 3M TEGADERM CHG PORT DRESSING DRESSING, WOUND OCCLUSIVE NAD 3M COMPANY, 3M HEALTHCARE 1665 201911AA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO