BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENFLON

    MDR report key: 3010942 · Received March 15, 2013

    Report

    Report Number
    2243072-2013-00009
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    December 15, 2012
    Report Date
    March 15, 2013
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER STATED THAT AN INFLAMMATORY REACTION HAS OCCURRED SHORTLY AFTER INSERTION OF BD VENFLON. ADDITIONAL INFO RECEIVED ON VIA E-MAIL ON (B)(6) 2013, THE PT WAS DISCHARGED FROM THE HOSPITAL AND HAD NOT BEEN RE-HOSPITALIZED. ON AN UNK DATE, PRIOR TO CANNULATION, THE INSERTION AREA WAS DISINFECTED WITH CODAN SPRAY, MEDICATION AND FLUIDS HAD BEEN GIVEN THROUGH THE CANNULAS, EVEN BEFORE THE INFLAMMATORY REACTION HAD OCCURRED. ON (B)(6) 2012, THE PT HAD A SURGICAL CONSULT AND IMPLEMENTATION OF ANTIBIOTICS, COMPRESSION WITH BICARBONICUM NATRIUM AND CLEXANE. ON AN UNK DATE, THE AREA HEALED AND THE IRRITATION/INFLAMMATION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110459 VENFLON CATHETER FOZ BECTON DICKINSON 12A1741G

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention