BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFSITE®

    MDR report key: 6118149 · Received November 21, 2016

    Report

    Report Number
    2523676-2016-00780
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    July 27, 2016
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04022495769862
    PMA / PMN Number
    K942988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT TEN OF B. BRAUN INC. INTERNAL REPORT # (B)(4). UNUSED SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES WERE SUBJECTED TO A LUER TAPER TEST AND A PRESSURE LEAKAGE TEST PER THE SPECIFICATIONS. NO VISUAL DEFECTS WERE FOUND, AND THE SAMPLES PASSED ALL TESTS. 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. BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. THE RETURNED SET MET REQUIREMENTS ACCORDING TO SPECIFICATION, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. 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 10. LEAKING OF BLOOD SALINE AND CONTRAST AT CONNECTION OF SAFSITE TO IV CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767378 SAFSITE® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061430768 04022495769862

    Patients

    Seq Age Sex Outcome Treatment
    1