BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVAC PICC

    MDR report key: 38257 · Received September 16, 1996

    Report

    Report Number
    2245270-1996-00028
    Event Type
    Injury
    Date Received
    September 16, 1996
    Date of Event
    September 9, 1996
    Report Date
    September 14, 1996
    Manufacturer
    VYGON GMBH ANF CO KG
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS BEING INSERTED INTO CEPHALIC VEIN FOR CENTRAL PLACEMENT. RESISTANCE WAS FELT. CLINICIAN STOPPED INSERTING AND CATHETER BOUNCED BACK. IT SEVERED AND EMBOLIZED TO THE LUNG. A TORNIQUET WAS APPLIED AND THE PT WAS TAKEN TO THE ER. THE EMBOLIZED PIECE WAS SUBSEQUENTLY REMOVED UNDER FLUOROSCOPY, IN RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVAC PICC PERIPHERAL INSERTED CENTRAL CATHETER DQO VYGON GMBH ANF CO KG 2190-10G 2268, C06A29

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other