BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7778098 · Received August 13, 2018

    Report

    Report Number
    9610847-2018-00257
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 10, 2018
    Report Date
    September 21, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    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

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER, D.8. DEVICE SINGLE USE?: NO, H.3. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: RECEIVED ONE USED Q-SYTE UNIT. THE DHR REVIEWS WERE PERFORMED ON THE SUB-ASSEMBLY LOT NUMBER: 7258521 WAS MANUFACTURED ON QFA LINE 2 STARTING ON JULY 21, 2017 THRU JULY 22, 2017. 7258525 WAS MANUFACTURED ON QFA LINE 3 STARTING ON SEPTEMBER 21, 2017 THRU SEPTEMBER 22, 2017. 7258526 WAS MANUFACTURED ON QFA LINE 3 STARTING ON SEPTEMBER 23, 2017 THRU SEPTEMBER 24, 2017. REVIEW OF THE DHR¿S REVEALED THAT ALL REQUIRED CHALLENGES SAMPLES, SET-UP AND IN-PROCESS TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE QUALITY SAMPLING PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. VISUAL/MICROSCOPIC EVALUATION: THE SEPTA HAD BEEN COMPLETELY PUSHED INTO THE Q-SYTE TOP BODY. THE RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS WAS EVIDENT ON THE RIM OF THE TOP BODY. THIS IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. PHOTO DISPLAYED THE SEPTUM PUSHED INTO THE TOP BODY. THE EVALUATION OF THE SEPTUM BEING PUSHED INTO ADAPTER LOCATION REVEALED EVIDENCE OF ADHESIVE AND SEPTUM DEPOSITS. THE OCCLUSION WAS FROM THE SEPTA BEING PUSHED INTO THE Q-SYTE TOP BODY. THIS IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. ¿NURSE FOUND SEPTUM PUSHED INTO ADAPTER DURING INFUSION AFTER USED 2 DAYS.¿ THIS SHOWS THE PROBLEM HAPPENED DURING USE. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE HAD A BROKEN JOINT MEMBRANE. 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 HAD A BROKEN JOINT MEMBRANE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620787 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7272685 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other