BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HICKMAN 9.6 FR SINGLE LUMEN CV CATHETER

    MDR report key: 1033697 · Received April 25, 2008

    Report

    Report Number
    2523003-2008-00045
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    July 20, 2007
    Report Date
    March 18, 2008
    Manufacturer
    C.R. BARD, INC (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A COMPLAINT HISTORY REVIEW SHOWED NO OTHER SIMILAR PROD COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    IN 2008, ACCORDING TO THE ATTORNEY LETTER, THE TUBE ON THE MEDICAL DEVICE RUPTURED NECESSITATING EMERGENCY SURGERY. IN ADDITION TO HAVING THE RUPTURED DEVICE REMOVED, THE PT HAD TO BE TREATED FOR A RESULTING INFECTION, AND HAVE ANOTHER VASCULAR ACCESS CATHETER PLACED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN 9.6 FR SINGLE LUMEN CV CATHETER LJS C.R. BARD, INC (BASD) 43GQP033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention