BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8960785 · Received September 4, 2019

    Report

    Report Number
    9610847-2019-00549
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 23, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED FOR THIS INCIDENT. A DHR WAS COMPLETED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FLOW RATE SLOW / OCCLUDED WITH LOT #7242775 REGARDING ITEM #385100. OBSERVATION AND/OR TESTING; COULD NOT BE CONDUCTED AS NO UNITS (SAMPLES) OR PHOTOS WERE PROVIDED FOR THIS INCIDENT OF THE ALLEGED DEFECT OF FLOW RATE SLOW / OCCLUDED. BECAUSE UNITS (SAMPLES) AND/OR PHOTOS WERE NOT PROVIDED FOR THIS INCIDENT, THE ALLEGED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT ESTABLISHED. WITHOUT A SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE PIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLOG OCCURRED DURING USE WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ON (B)(6) 2019, THE PATIENT USED Q-SYTE CONNECTOR FOR THE POSTOPERATIVE INFUSION. THE CONNECTOR WAS FOUND TO BE CLOGGED DURING USE, AND THE NEW INFUSION CONNECTOR WAS REPLACED IMMEDIATELY. THE INCIDENT WAS FOUND TO HAVE NO ADVERSE EFFECTS ON THE PATIENT IN TIME."

    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 CLOG OCCURRED DURING USE WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ON (B)(6) 2019, THE PATIENT USED Q-SYTE CONNECTOR FOR THE POSTOPERATIVE INFUSION. THE CONNECTOR WAS FOUND TO BE CLOGGED DURING USE, AND THE NEW INFUSION CONNECTOR WAS REPLACED IMMEDIATELY. THE INCIDENT WAS FOUND TO HAVE NO ADVERSE EFFECTS ON THE PATIENT IN TIME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756966 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7242775 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other