BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, BASIC T

    MDR report key: 2181129 · Received July 22, 2011

    Report

    Report Number
    3006260740-2011-00256
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    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 MFR FOR EVAL AS IT REMAINS IN THE PT. A LOT HISTORY REVIEW (LHR) OF (B)(6) 2011 SHOWED THREE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PT EXPERIENCED SHORTNESS OF BREATH IMMEDIATELY UPON FLUSHING THE INSERTED PICC. SYMPTOMS RESOLVED AFTER 30 MINS. ADD'L INFO: "SHE WAS NERVOUS BEFORE THE PROCEDURE AND ASKING LOTS OF QUESTIONS. SHE WAS GIVEN ATIVAN 1MG AND THEY LEFT BECAUSE SHE HAD A DRAIN IN HER BACK WHICH BROKE. THEY HAD TO LEAVE WHILE DRAIN WAS REPAIRED. CAME BACK ABOUT 45 MINS LATER. SHE COMPLAINED OF LEG ITCHINESS PRIOR TO STARTING THE CASE. (B)(6) WAS CONCERNED BY THIS AND HAD GUT FEELING THIS PT WOULD REACT. SHE REQUESTED BENADRYL FOR CART PRIOR TO PROCEDURE. FOUR OF 5 PTS WHO'VE REACTED HAVE BEEN ABORIGINAL. THIS PT WAS AND IT TRIGGERED (B)(6) TO ORDER BENADRYL. THE PT REACTED IMMEDIATELY AFTER THE PICC WAS FLUSHED. SHE COULD NOT TALK FOR 8 MINS AND EXPERIENCED SHORTNESS OF BREATH AND WAS NOT RESPONDING TO VERBAL STIMULI. SHE RETURNED TO NORMAL VERY QUICKLY. PICC WAS LEFT IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, BASIC T LJS C.R. BARD, INC. (BASD) REVB0768

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention CLOXACYLIN 2G EVERY 4 HRS| CIPROFLOXACIN 750MG - GIVEN AFTER THE PICC| ATIVAN| INSERTION, NOT FOR REACTION TREATMENT