BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG 9.5 FR D/L CV CATHETER

    MDR report key: 1033695 · Received April 25, 2008

    Report

    Report Number
    2523003-2008-00048
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 1, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K860256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW IS NOT POSSIBLE; THE MANUFACTURING LOT NUMBER THAT WAS PROVIDED IS AN INCORRECT MANUFACTURING LOT NUMBER.

    Description of Event or Problem · 1

    COMPLETED A BLOOD DRAW WITHOUT INCIDENT, BUT DURING INFUSION THE PT FELT PAIN. A DYE STUDY WAS ORDERED WHICH REVEALED A CRACK IN THE CATHETER. THE DEVICE WAS REMOVED AND REPLACED TWO DAYS LATER. THE PT HAS DEVELOPED A STAPH INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 9.5 FR D/L CV CATHETER FOZ C.R. BARD, INC. (BASD) RERG0547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention