BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR DL POWERPICC UPFT WITH MI AND TLS

    MDR report key: 2103732 · Received May 16, 2011

    Report

    Report Number
    3006260740-2011-00142
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 12, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    AFTER THE PT HAD THE PICC PLACED W/OUT ISSUE AND THE DRESSING PLACED, THE PT SAID THEY FELT HOT, THEY STARTED TO ITCH. FACE AND CHIN WERE "BURNING", BLOOD PRESSURE WAS DOWN (60/40), HEART RATE OF 140, THEN EYES IN BACK OF HEAD. THEY PULLED PICC OUT GAVE OXYGEN, IN 10 MINUTES PT WAS ALERT AND MUCH BETTER. THEY DOUBLE CHECKED THE SET UP AND INSERTION AND DID NOT FIND ANY ISSUES. PICC WENT IN W/OUT ISSUE OR CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC UPFT WITH MI AND TLS LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention