BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC KIT

    MDR report key: 1003359 · Received February 4, 2008

    Report

    Report Number
    1036844-2008-00008
    Event Type
    Injury
    Date Received
    February 4, 2008
    Date of Event
    December 4, 2007
    Report Date
    February 4, 2008
    Manufacturer
    ARROW INT'L INC
    Product Code
    LJS
    PMA / PMN Number
    K042126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH THAT THE "PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE BROKE OFF AND HAD TO BE RETRIEVED THROUGH #6 FR SHEATH - PULLED AFTER 15 MIN PRESSURE. PICC REMOVED FROM RIGHT COMMON FEMORAL VEIN THUS HAPPENED AT SKILLED NURSING FACILITY." FURTHER INFO RECEIVED INDICATES THAT THE PICC WAS INSERTED IN 2007 AT A MED CTR. THE PT WAS RETURNED TO A NURSING HOME WHEN THE PICC LATER BROKE. AN X-RAY CONFIRMED THAT IT HAD BROKEN, AND A PIECE WAS AT THE ENTRANCE OF THE SUPERIOR VENA CAVA. THE PT WAS RETURNED TO THE MED CTR FOR EVAL AND REMOVAL ON APPROX ONE AND A HALF MONTHS LATER. THE MEDICAL STAFF SURGICALLY REMOVED THE PIECE OF CATHETER. THERE IS NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC KIT PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INT'L INC * RF7066015

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention