BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 19 CM (PRE-CURVE)

    MDR report key: 3162441 · Received June 6, 2013

    Report

    Report Number
    3006260740-2013-00282
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    March 23, 2013
    Report Date
    May 16, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LFJ
    PMA / PMN Number
    K871488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REUF0226 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    BLOOD COMING OUT OF CATHETER DURING DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251454 SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 19 CM (PRE-CURVE) LFJ C. R. BARD INC. (BASD) REUF0226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention