BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR DL POWERPICC UPFT WITH MI AND TLS

    MDR report key: 2030686 · Received March 18, 2011

    Report

    Report Number
    3006260740-2011-00079
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 14, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL AS IT REMAINS IN USE. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PT HAD A SEVERE RAPID-ONSET REACTION IMMEDIATELY UPON FLUSHING THE PICC AFTER IT HAD BEEN PLACED AND THE TLS WIRE REMOVED. THE REACTION INCLUDES SUDDEN GASPING/CHOKING, RED IN FACE, "CAN'T BREATH", PANIC, BLOOD PRESSURE GOES UP, O2 SAT GOES DOWN, THE REACTION SUBSIDES WITHIN 5 MINUTES. THE EYES ROLL BACK AT THE ONSET OF THE REACTIONS.

    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) REUI1040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention