BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45 CM 5FR. D/L GROSHONG NXT BASIC WITH MI AND TLS

    MDR report key: 2162028 · Received July 12, 2011

    Report

    Report Number
    3006260740-2011-00218
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K060341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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) OF REUK1276 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED DIFFICULTY BREATHING AND SWOLLEN EYES AND LIPS AFTER PICC INSERTION. HE WAS GIVEN BENADRYL AND OXYGEN. PICC WAS LEFT IN. SYMPTOMS RESOLVED AFTER ONE HOUR. ADDITIONAL INFORMATION: STARTED FIVE MINUTES AFTER THE TEGADERM DRESSING WAS APPLIED. FIRST COMMENTS WERE THAT HIS BACK IS VERY ITCHY. LIDOCAINE (WHEN HE INJECTED IT THE PT NOTICED THAT HE COULD TASTE IT). ONCE HE WAS DRAPED HE COMMENTED THAT HE WAS NERVOUS. STARTED WITH HIM COMMENTING THAT HE FEELS ITCHY AND THEN SAID HIS FACE FELT NUMB. BREATHING STARTED TO BECOME LABORIOUS AND HE WAS GIVEN OXYGEN. NO HIVES BUT SWOLLEN EYES AND UPPER LIP. HE WAS GIVEN OXYGEN BECAUSE HE WAS HAVING TROUBLE BREATHING. NOT TALKING BUT ALERT. THEY CHECKED BLOOD PRESSURE BUT IT WAS HARD TO GET. O2 STATS WAS INITIALLY 75% AT ONSET OF REACTION AND THEN GIVEN 15L OF OXYGEN FOR 10 MINUTES UNTIL O2 STATS RETURNED TO 95%. OXYGEN LOWERED TO 12L AND THEN LEFT FOR AN HOUR OR SO. IT WAS HARD TO TELL IF HE WAS FLUSHED. HIS WIFE SAID THAT HE WAS RED BUT HARD FOR STAFF TO TELL BECAUSE OF UNUSUAL SKIN APPEARANCE. BENADRYL 50MG WAS GIVEN AFTER REACTION STARTED. PT WAS ALLERGY TESTED AFTER REACTION. HE WAS FOUND TO BE ALLERGIC TO IGE, ALSO PREVIOUSLY KNOWN ALLERGIES: CONTRAST DYE AND RAMIPRIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45 CM 5FR. D/L GROSHONG NXT BASIC WITH MI AND TLS FOZ C. R. BARD, INC. (BASD) REUK1276

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention