BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, FULL TRAY WITH MI

    MDR report key: 1914193 · Received December 1, 2010

    Report

    Report Number
    3006260740-2010-00355
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 29, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    FOUR FR SINGLE LUMEN GROSHONG WAS INSERTED AND WHEN THE PICC WAS FLUSHED WITH THE SALINE FROM THE KIT THE PT EXPERIENCED SHORTNESS OF BREATH, CHEST PAIN AND PANIC. WHEN SALINE WAS BEING FLUSHED, PT EXPERIENCED SHORTNESS OF BREATH, ANXIETY, AND "EYES ROLLED BACK." REACTION WAS TRANSIENT, SO THERE WAS NO NEED TO CALL A RAPID RESPONSE. NO VITAL SIGNS WERE TAKEN. REACTION BEGAN WHEN PICC WAS BEING FLUSHED, PRIOR TO DRESSING, PRIOR TO CLEANING THE SITE, AND AFTER STYLET WAS REMOVED. WHEN PLACEMENT WAS CHECKED, THE TIP OF THE CATHETER WAS "2 CM TOO FAR," AT THE ENTRANCE TO THE RIGHT ATRIUM. CATHETER WAS PULLED BACK 2 CM, AND PICC REMAINS IN THE PT. RN FLUSHES WITH "RAPID" SALINE FLUSH TO CLEAR THE LINE OF BLOOD AFTER CHECKING ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, FULL TRAY WITH MI LJS C. R. BARD INC. (BASD) REUF0015

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention