BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8030374 · Received November 1, 2018

    Report

    Report Number
    9610847-2018-00362
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 12, 2018
    Report Date
    December 5, 2018
    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

    H.6. INVESTIGATION SUMMARY: 7265564 WAS BUILT ON QFA LINE 3, FROM 27SEP2017 THROUGH 28SEP2017 FOR THE QUANTITY OF 180,000EA. 1 NON-RELATED QN (2001710844) FOR TORQUE PAINT BROKE WAS INITIATED WHERE DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED PER QUALITY CONTROL PLAN. 7265566 WAS BUILT ON QFA LINE 3, FROM 29SEP2017 THROUGH 01OCT2017 FOR THE QUANTITY OF 196,429EA. 1 NON RELATED QN (200711028) WELD FLASH WAS INITIATED. WHERE DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED PER QUALITY CONTROL PLAN. 7265567 WAS BUILT ON QFA LINE 4, FROM 28SEP17 THROUGH 30SEP2017 FOR THE QUANTITY OF 208,330EA. NO QN WERE INITIATED DURING PRODUCTION. ALL OTHER CHALLENGE, SET-UP, IN PROCESS SAMPLES AND TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. RECEIVED A TOTAL OF 18 Q-SYTE UNITS WITHIN SEALED PACKAGES FROM LOT NUMBER 7272687. ALL THE CONTENTS WITHIN THE PACKAGES WERE PRESENT. PROVIDE RESULTS, ANY TESTING PERFORMED, AND OTHER RELEVANT INFORMATION NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED DURING THE VISUAL OBSERVATIONS. THE SEPTUMS WERE GLUED TO THE RIM OF THE Q-SYTE (PER SPEC). THE WATER-LEAK TEST WAS PERFORMED AND NO LEAKAGE WAS OBSERVED ON EITHER THE ACTUATED OR THE UNACTUATED POSITIONS. INDETERMINATE: THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY.

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS ARE AS FOLLOWS: MEDICAL DEVICE MANUFACTURER: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. MANUFACTURING LOCATION: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED FROM THE TOP OF THE SEPTUM. THE SEPTUM BECAME UNGLUED WHEN USING PICC. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED FROM THE TOP OF THE SEPTUM. THE SEPTUM BECAME UNGLUED WHEN USING PICC. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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 A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED FROM THE TOP OF THE SEPTUM. THE SEPTUM BECAME UNGLUED WHEN USING PICC. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867251 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7272687 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other