BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2030719 · Received March 18, 2011

    Report

    Report Number
    3006260740-2011-00084
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    March 15, 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 EVAL AS IT REMAINS IN USE. A CHR 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 THE PICC WAS INSERTED. WHILE REMOVING STERILE FIELD, PT SUDDENLY HAD RED FACE AND FELT HOT FLUSHING. IT SETTLED IN 5 MINUTES. ADDITIONAL INFO: PT BECAME FLUSHED (RED FACE), DIAPHORETIC AND C/O SOB: AFTER SHE RECOVERED, PT STATED "SHE TASTED SOMETHING ODD"; RN STRONGLY FELT IT WAS A REACTION TO THE LIDOCAINE. HE DID NOT KNOW IF SHE HAD RECEIVED LOCAL ANESTHESIA IN THE PAST. THE SOB WAS LIKE A SWELLING OF THE THROAT AS SEEN IN ANAPHYLAXIS. REACTION OCCURRED AFTER REMOVING STERILE FIELD AND APPLYING THE DRESSING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention