BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45 CM, 5 FR. S/L POWERGROSHONG, BASIC KIT

    MDR report key: 1910429 · Received November 18, 2010

    Report

    Report Number
    3006260740-2010-00342
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 27, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELT PAIN IN THE ARM DURING INFUSION. THEY WERE SENT TO RADIOLOGY FOR X-RAY AND PICC WAS FOUND SEVERED. DISTAL END OF RIGHT ATRIUM. THE PICC WAS REMOVED, AND RETRIEVAL WAS REQUIRED TO GET DISTAL END OF PICC FLOATING FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45 CM, 5 FR. S/L POWERGROSHONG, BASIC KIT LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention