BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGEL LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    MDR report key: 1150481 · Received September 5, 2008

    Report

    Report Number
    1820334-2008-00487
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 7, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE RETURNED OPENED AND USED DEVICE CONFIRMED THE VALIDITY OF THIS REPORT. WE CAN ADVISE THIS DEVICE IS VISUALLY INSPECTED 100% PRIOR TO FURTHER PROCESSING. WE ARE UNABLE TO DETERMINE HOW/WHY THIS SITUATION MAY HAVE OCCURRED, HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    PT WAS AT HOME WITH IV ANTIBIOTICS, RETURNED TO THE HOSP AS THE LINE BECAME DISLODGED, WITH DISTAL PORTION REMAINING IN SITU. THE DEVICE HAD BEEN IN THE PT FOR 18 DAYS. PT WAS DISCHARGED FROM THE HOSP IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGEL LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA F2217706

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R