BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2113544 · Received June 1, 2011

    Report

    Report Number
    3006260740-2011-00159
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 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 MFR FOR EVAL. A LHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A REACTION AFTER A PICC INSERTION. THE PICC WENT IN SMOOTH AND THEY FLUSHED. WHEN DRESSING THE PICC, THE PT SAT UP SUDDENLY AND ASKED WHAT THEY HAD GIVEN HER. SHE WAS WORRIED, TURNED RED AND DEVELOPED A HIVE. BREATHING AND VITALS REMAINED NORMAL. SYMPTOMS RESOLVED WITHIN 2 MINUTES AND THE PT IS FINE. THE PICC REMAINS IN THE PT.

    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) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention