BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F

    MDR report key: 3223869 · Received July 10, 2013

    Report

    Report Number
    3006260740-2013-00333
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 17, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE REMAINS IN THE PT. A LOT HISTORY REVIEW (LHR) OF REXD0805 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PT REACTION WHEN CATHETER WAS FLUSHED. PT FLUSHES AND FEELS SHORT OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315211 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F LJS C. R. BARD INC. (BASD) REXD0805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention