BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL SINGLE KIT

    MDR report key: 2123445 · Received June 9, 2011

    Report

    Report Number
    2183502-2011-00474
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE PRODUCT WAS PULLED SLIGHTLY AND BLOOD LEAKAGE OCCURRED. NO ADVERSE EFFECTS TO PT OR USERS REPORTED. THERE WAS NO REPORTED PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL SINGLE KIT PRESSURE MONITORING SET DRS SMITHS MEDICAL INTERNATIONAL LTD. NA 1961016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK