BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 8578453 · Received May 3, 2019

    Report

    Report Number
    9610847-2019-00353
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 16, 2019
    Report Date
    June 10, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED A Q-SYTE UNIT IN AN OPENED PACKAGE FROM LOT 8178559 FOR EVALUATION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED TEARS ON THE SLIT OF THE TOP DISK OF THE SEPTUM. THE TOP DISK APPEARED TO BECOMING UNGLUED FROM THE RIM AND PUSHED INTO THE ADAPTER. HOWEVER, THERE WAS EVIDENCE OF ADHESIVE FOUND ON THE RIM OF THE UNIT. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. THE ENGINEER WAS UNABLE TO DETERMINE THE DEFINITIVE ROOT CAUSE FOR THIS ISSUE SINCE THE UNIT WAS RETURNED IN AN OPENED PACKAGE AND THERE WAS EVIDENCE OF A STABLE BOND MADE DURING PRODUCTION. DHR REVIEWS: LOT # 8137786: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 24MAY18 THROUGH 26MAY18. A POTENTIALLY RELATED QN ((B)(4)-SEPTUM DAMAGED) WAS INITIATED DURING PRODUCTION. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED PER CONTROL PLAN. LOT # 8142519: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON QFA LINE 3 STARTING ON 29MAY18 THROUGH 31MAY18. A POTENTIALLY RELATED QN ((B)(4)-BOND STRENGTH OOS) WAS INITIATED DURING PRODUCTION. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED PER CONTROL PLAN. LOT # 8152559: A TOTAL OF (B)(4) WERE MANUFACTURED ON QFA LINE 3 STARTING ON 4JUN18 THROUGH 6JUN18. NO QUALITY NOTIFICATION WERE INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS CONNECTED TO PICC TUBING, AND THE SEPTUM PUSHED INTO THE ADAPTER AND UNGLUED FROM THE RIM AFTER THE THIRD DAY OF PLACEMENT, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "Q-SYTE CONNECTOR WAS CONNECTED TO THE PICC TUBING. LEAKAGE WAS NOTICED ON THE 3RD DAY OF PLACEMENT, THE SEPTUM SUNK IN AND UNGLUED AT THE RIM AFTER CHECKED. THE CUSTOMER FEEDBACK THAT IT MIGHT BE CAUSED BY HIGH FREQUENCY OF USE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS CONNECTED TO PICC TUBING, AND THE SEPTUM PUSHED INTO THE ADAPTER AND UNGLUED FROM THE RIM AFTER THE THIRD DAY OF PLACEMENT, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "Q-SYTE CONNECTOR WAS CONNECTED TO THE PICC TUBING. LEAKAGE WAS NOTICED ON THE 3RD DAY OF PLACEMENT, THE SEPTUM SUNKED IN AND UNGLUED AT THE RIM AFTER CHECKED. THE CUSTOMER FEEDBACKED THAT IT MIGHT BE CAUSED BY HIGH FREQUENCY OF USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372393 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8178559 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other