BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMODIALYSIS NON-IMPLANTED

    MDR report key: 2912826 · Received January 9, 2013

    Report

    Report Number
    3006260740-2013-00023
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 27, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PT ATTENDED FOR ROUTINE TREATMENT. DIALYSIS SESSION COMMENCED AND BLEEDING NOTED COMING OUT FROM LINE. NOTED INCREASING NEGATIVE ARTERIAL PRESSURE AND MACHINE STARTED TO ALARM. NO PT INJURY. TREATMENT DISCONTINUED. RENAL CONSULTANT NOTIFIED AND ADVISED TO TRANSFER PT TO (B)(4) FOR REVIEW OF ACCESS AND LINE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11988 HEMODIALYSIS NON-IMPLANTED SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR MPB C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention