BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFSITE®

    MDR report key: 6120330 · Received November 22, 2016

    Report

    Report Number
    2523676-2016-00790
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Report Date
    September 25, 2014
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964184697
    PMA / PMN Number
    K942988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT ONE OF B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. NOTE: THIS CASE IS BEING FILED RETROSPECTIVELY AS A RESULT OF A REVIEW OF RECENT CUSTOMER COMPLAINT INFORMATION. BASED ON ADDITIONAL INFORMATION AND DETAILS PROVIDED IN ANOTHER COMPLAINT CASE, IT WAS DETERMINED THAT THIS CASE IS REPORTABLE IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. B. BRAUN HAS CONDUCTED A RETROSPECTIVE REVIEW FOR ALL COMPLAINTS OF A SIMILAR NATURE IN ACCORDANCE WITH INTERNAL PROCEDURE COP-QP-8000051.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: EVENT 1. LEAKING AT THE CONNECTION WITH THE TUBING AND THE SAFSITE. LEAK BLOOD ALL OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773896 SAFSITE® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061346028 04046964184697

    Patients

    Seq Age Sex Outcome Treatment
    1