BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR. S/L POWERPICC - NURSING FULL (TLS)

    MDR report key: 2050951 · Received April 4, 2011

    Report

    Report Number
    3006260740-2011-00096
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 28, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT SAID SHE HAD A "FUNNY FEELING" JUST BEFORE THE SYMPTOMS STARTED. SHE C/O CHEST PRESSURE, FEELING HOT (SHE WAS FLUSHED THROUGHOUT HER FACE AND NECK, VERY RED), CAN'T BREATHE, THROAT CLOSING. THIS PATIENT WAS VERY NERVOUS ABOUT HAVING THE PICC INSERTED. SHE WAS AFRAID OF THE PAIN. THE SYMPTOMS ONLY LASTED ABOUT 5 MIN., THE PICC TIP WAS LOCATED ABOUT 3CM FROM THE RA/SVC JUNCTION. I DID PULL BACK 2CM WHEN THE SYMPTOMS OCCURRED. VITAL SIGNS WERE STABLE, NO OXYGEN WAS NEEDED, LUNGS WERE CLEAR. WE JUST SAT HER UPRIGHT AND GAVE HER A COLD WET WASHCLOTH AND SOME ICE WATER. SHE WENT ON TO RECEIVE A DOSE OF INVANZ AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR. S/L POWERPICC - NURSING FULL (TLS) LJS C. R. BARD, INC. (BASD) REUK0991

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention