BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7814461 · Received August 24, 2018

    Report

    Report Number
    9610847-2018-00281
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    August 4, 2018
    Report Date
    September 10, 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 (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES. INVESTIGATION SUMMARY: RECEIVED A Q-SYTE UNIT WITH NO PACKAGING MATERIAL. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FLOW RATE SLOW / OCCLUDED WITH LOT #7209846 REGARDING ITEM #385100. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SEPTUM PUSHED INTO ADAPTER (Q-SYTE) WITH LOT #7209846 REGARDING ITEM #385100 DHR REVIEW: 7212772: THE LOT WAS BUILT ON QFA LINE 3 FROM 6AUG17 THRU 8AUG17 FOR THE QUANTITY OF 180,000EA. 7212775: THE LOT WAS BUILT ON QFA LINE 3 FROM 8AUG17 THRU 10AUG17 FOR THE QUANTITY OF 180,000EA. ALL REQUIRED CHALLENGE, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED PER PROCEDURE AND ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE DISCLOSED AS IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOTS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL/MICROSCOPIC EXAMINATION: DAMAGE (TEARS) ON THE TOP SEPTUM DISK WAS OBSERVED . THE SEPTUM WAS NOT PUSHED INTO THE ADAPTER OR LIFTED FROM THE RIM OF THE Q-SYTE BODY. DURING PROBE INSERTION IT WAS CONFIRMED BOTH THE TOP AND BOTTOM SLITS WERE PRESENT AND NO TEARS WERE ON THE COLUMN WALL. OBSERVED MINOR DAMAGE ON THE TOP BODY OF THE BODY. THE WATER FLOWED FREELY INTO THE Q-SYTE UNIT AND OUT WITH NO OBSTRUCTION. FLOW TEST: THE FLOW TEST PASSED PER SPECIFICATION OF 1 LITER/HOUR WITH THE RESULT OF 35.39 L/H PROBABLE ROOT CAUSE FOR THIS INCIDENT IS INDETERMINATE. THE RETURNED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED IN THE LABORATORY. THE MINOR DAMAGE FOUND ON THE Q-SYTE TOP BODY WAS MOST LIKELY CAUSED BY EXTERNAL FORCES USED DURING USAGE AND WOULD NOT CONTRIBUTE TO THE FAILURE EXPERIENCED BY THE CUSTOMER. 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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656231 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7209846 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other