BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERFLOW® FILTERED EXTENSION SETS

    MDR report key: 5485670 · Received March 8, 2016

    Report

    Report Number
    9614279-2016-00005
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Date of Event
    January 19, 2016
    Report Date
    February 9, 2016
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC INC.
    Product Code
    FPA
    PMA / PMN Number
    K942988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED FILTERED EXTENSION SET, WITHOUT PACKAGING, WAS RECEIVED FOR EVALUATION. THE SET WAS CONNECTED TO A PRIMARY DRIP CHAMBER SET. THE PRIMARY SET WAS REMOVED, AND THE FILTERED EXTENSION SET WAS SUBJECTED TO AN AIR PRESSURE (LEAKAGE) TEST ACCORDING TO SPECIFICATION. LEAKAGE WAS OBSERVED AT THE SONIC WELD SEAL OF THE ULTRASITE Y VALVE. IN ORDER TO INVESTIGATE INCIDENTS RELATED TO ULTRASITE Y VALVES WHICH LEAK FROM THE SONIC WELD (LUER NUT-PISTON-BODY INTERFACE), B. BRAUN MEDICAL INC. OPENED A CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) TO FURTHER INVESTIGATE ROOT CAUSE AND IDENTIFY ANY NECESSARY CORRECTIVE ACTION. BASED ON THE INITIAL CAPA INVESTIGATION, TOP POTENTIAL CAUSES HAVE BEEN IDENTIFIED AS WELDER OUTPUT VARIATIONS ON CERTAIN WELDER AND ULTRASONIC STACK COMBINATIONS OR HAVING AN UNSEATED LUER NUT IN COMBINATION WITH CERTAIN WELD PARAMETERS. THIS CAPA IS CURRENTLY IN IMPLEMENTATION PHASE TO EXECUTE THE CAPA ACTION PLAN, WHICH INCLUDES DEVELOPING AND TESTING METHODS FOR MEASURING AND CONTROLLING WELDER OUTPUT, AND REVISING THE WELD PROCESS TO ELIMINATE CONDITIONS THAT CAN CREATE AND UNSEATED LUER NUT. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE TUBING SET LEAKED AT THE CONNECTION OF THE PORT. CHEMO MEDICATION WAS IN THE TUBING AT THE TIME OF LEAKAGE. THE REPORTER IS UNSURE OF WHAT SPECIFIC CHEMO DRUG WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144328 FILTERFLOW® FILTERED EXTENSION SETS FILTERED EXT SET W/ ULTRASITE VALVE FPA B. BRAUN DOMINICAN REPUBLIC INC. US1380F 0061455215

    Patients

    Seq Age Sex Outcome Treatment
    1