BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE TWINFLO 2 FRENCH D/L PUR XRO CATHETER WITH MICROFLASH INTRO AND NEONAT

    MDR report key: 7534082 · Received May 21, 2018

    Report

    Report Number
    MW5077380
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 17, 2018
    Manufacturer
    VYGON USA
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PICC DRESSING CHANGE STARTED DUE TO DRIED BLOOD UNDER DRESSING AND DRESSING LIFTING AT INSERTION SITE. OLD DRESSING REMOVED AND DRIED BLOOD REMOVED FROM CATHETER AND INSERTION SITE WITH STERILE ALCOHOL AND CHLORAPREP SWABS. PICC NOTED TO BE LEAKING DISTAL TO INSERTION SITE. MD AND NNP NOTIFIED AND VIEWED. PICC PULLED AND PIV PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372167 NUTRILINE TWINFLO 2 FRENCH D/L PUR XRO CATHETER WITH MICROFLASH INTRO AND NEONAT CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS VYGON USA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA