BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7659568 · Received July 3, 2018

    Report

    Report Number
    9610847-2018-00195
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 14, 2018
    Report Date
    August 17, 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

    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 MANUFACTURER: YES. INVESTIGATION SUMMARY: SUB ASSEMBLY LOTS FOR BATCH 7178869 DHR REVIEW. 7131959 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM MAY 29, 2017 THRU JUNE 1, 2017. 7143619 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM JUNE 9, 2017 THRU JUNE 11, 2017. 7143620 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM JUNE 1, 2017 THRU JUNE 3, 2017. 7143621 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM JUNE 3, 2017 THRU JUNE 5, 2017. REVIEW OF THE DHRS REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. VISUAL/MICROSCOPIC EXAMINATION: ALL UNITS WERE MOLDED USING THE 16 CAVITY MOLD. DAMAGE (TEARS) ON THE TOP SEPTUM DISK AND ON THE SLIT OF THE SEPTUM ON ALL UNITS. DURING PROBE INSERTION IT WAS CONFIRMED BOTH THE TOP AND BOTTOM SLITS WERE PRESENT AND NO TEARS WERE ON THE COLUMN WALL. THE WATER FLOWED FREELY INTO THE Q-SYTE UNITS AND OUT WITH NO OBSTRUCTION. FLOW TEST: THE FLOW TEST PASSED PER SPECIFICATION OF 1 LITER/HOUR WITH THE FOLLOWING RESULTS: 1. UNIT 1 = 33.66 L/H. 2. UNIT 2 = 30.34 L/H. 3. UNIT 3 = 27.03 L/H. 4. UNIT 4 = 29.58 L/H. FLOW RATE WAS SUCCESSFUL, NO OBSTRUCTION WAS OBSERVED ON ANY OF THE RECEIVED UNITS. A DEFINITE SOURCE THAT CAUSED THE DAMAGE ON THE SEPTUM TOP DISK AND SLIT COULD NOT BE ESTABLISHED BASED ON THE EVALUATION OF THE USED UNIT. THE DAMAGE APPEARS TO BE CAUSED BY EXTERNAL FORCES APPLIED TO THE UNIT DURING USAGE. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A DEFINITE ROOT CAUSE THAT CAUSED THE DAMAGE OBSERVED WITH THE RETURNED UNIT COULD NOT BE IDENTIFIED. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SLOW FLOW WAS OCCURRING IN A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THERE WAS NO REPORT OF EXPOSURE, 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 SLOW FLOW WAS OCCURRING IN A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499758 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LUER ACCESS SPLIT SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7178869 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other