BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWO-LUMEN CENTRAL VENOUS CATHETERIZATION KIT WITH BLUE FLEXT

    MDR report key: 3674055 · Received February 13, 2014

    Report

    Report Number
    3674055
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    December 13, 2013
    Report Date
    February 13, 2014
    Manufacturer
    ARROW INTERNATIONAL, A SUBSIDIARY OFTELEFLEX INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    DOUBLE LUMEN PICC - TUBING SNAPPED ABOVE POA (POINT OF ATTACHMENT). THIS DEVICE IS PART OF A PICC KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95618 TWO-LUMEN CENTRAL VENOUS CATHETERIZATION KIT WITH BLUE FLEXT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 D FOZ ARROW INTERNATIONAL, A SUBSIDIARY OFTELEFLEX INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *