BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTED PICC

    MDR report key: 3050210 · Received April 4, 2013

    Report

    Report Number
    3006260740-2013-00145
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    March 12, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS INCONCLUSIVE SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    TWO ARTERIAL PLACED PICC LINES WITH 3CG. NO SIGNS THAT IT WAS ARTERIAL WHEN PLACED. THIS CAN MEDICALLY HAPPEN IF PATIENT HAS LOW PRESSURES OR LOW EJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137607 UNKNOWN IMPLANTED PICC UNK LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention