BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ EXTENSION SET

    MDR report key: 7366625 · Received March 23, 2018

    Report

    Report Number
    9610847-2018-00077
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 19, 2018
    Report Date
    March 22, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K142527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INSPECTION OF THE RETURNED SAMPLE CONFIRMED THE REPORTED ISSUE. THIS OCCURRENCE IS MANUFACTURING RELATED AND OCCURRED DUE TO HUMAN ERROR. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINT HISTORY CHECK FOR LOT 7149680 WAS VERIFIED AND NO DISCREPANCIES WERE FOUND ABOUT THE ABOVE DESCRIBED PROBLEM. REF NO: (B)(4), PRODUCT DESC: Q-SYTE EXT SET , MFG CODE: 7149680, SUBJECT DESC: VENT PLUG/ LOOSE/ MISSING. NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 7149680 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. LOT NO #: 7149680 CATALOG #: NS385151, QUANTITY PRODUCED: (B)(4) PCS. BD EXT SET LOTS (P/N 500005371) USED ARE AO16G04 AND AO16G05 FOR LOT 7149680. Q-SYTE LOTS (P/N 8004149) USED ARE 7100582 AND 7100594 FOR LOT 7149680. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7149680. DURING THE MANUFACTURE OF THIS PRODUCT, 100% VISUAL INSPECTION IS PERFORMED BEFORE PACKAGING THE PRODUCT IN BLISTERS LOOKING FOR ANY MISSING COMPONENTS INSIDE THE PACKAGE. DURING THE 100% INSPECTION, NO PARTS WERE DETECTED WITH MISSING COMPONENTS BY OUR OPERATORS. FAILURE MODE CONFIRMED (MISSING Q-SYTE CONNECTOR). THIS MAY BE CAUSED BY A HUMAN ERROR TO FOLLOW UP PROCEDURES AND/OR INSUFFICIENT TRAINING FOR NEW OPERATORS DURING THE Q-SYTE TORQUE OPERATION. NEW UNTRAINED OPERATORS WERE PERFORMING THE Q-SYTE TORQUE OPERATION AND 100% SELF- PACKAGING INSPECTION. THE OPERATOR SHOULD TAKE ONLY ONE ASSEMBLY AT A TIME (ONE PIECE FLOW), APPLY THE TORQUE AND PUT IT INTO THE CONTAINER AS PER INSTRUCTIONS TO PREVENT ESCAPES. IF THE OPERATOR TAKES MORE THAN ONE PART TO SPEED UP THIS ASSEMBLY PROCESS, SHE/HE CAN CAUSE THIS FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD Q-SYTE¿ EXTENSION SET THERE IS MISSING PRODUCT WHICH MAY LEAD TO INJURY. THE CONSUMER STATES ¿THE BIDIRECTIONAL VALVE IS MISSING ON THE EXTENSION SET. MEANING THAT THE SET CANNOT BE USED.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210884 BD Q-SYTE¿ EXTENSION SET LUER ACCESS SPLIT SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7149680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other