BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED PICC

    MDR report key: 3233811 · Received July 15, 2013

    Report

    Report Number
    3006260740-2013-00343
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE REMAINS IN THE PT. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PICC INSERTION. DURING INSERTION AT THE RIGHT BASILIC VEIN THERE WAS A REACTION. THERE WAS RESISTANCE AT THE SUBCLAVIAN, LINE GOING TO RIGHT IJ. THE REACTION WAS NAUSEA, DIFFICULTY TAKING A DEEP BREATH, "PULSATING ACTION IN KIDNEYS", EXTREME FACIAL FLUSHING AND HEAT SENSATION LASTING 2-3 MIN, SENSATION OF SWELLING LIPS. OXYGEN APPLIED BY FACE MASK, VITAL SIGNS TAKEN, COLD CLOTH TO FOREHEAD FOR FACIAL FLUSHING AND HOT FACE SENSATION. PT RETURNED TO NORMAL AFTER APPROX 10 MIN. THE PICC REMAINS IN THE PT'S RIGHT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327769 IMPLANTED PICC PERCUTANEOUS IMPLANTED LONG TERM LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention