BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7222518 · Received January 26, 2018

    Report

    Report Number
    9610847-2018-00004
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 5, 2018
    Report Date
    February 8, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: TWELVE SAMPLE UNITS WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, NO DAMAGES WERE OBSERVED TO ANY OF THE EXTERNAL Q-SYTE COMPONENTS. A WATER LEAKAGE TEST SHOWED NO LEAKAGE IN THE UN-ACTUATED OR THE ACTUATED POSITIONS. A SEPTUM COLUMN TEAR ASSESSMENT WAS PERFORMED, NO DAMAGES WERE OBSERVED ALONG THE COLUMN WALL. A SMALL TEAR WAS OBSERVED ON THE SEPTUM BOTTOM DISK OF ONE UNIT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A ROOT CAUSE COULD NOT BE DETERMINED. DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY LOT NUMBERS: 7072824 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM MARCH 18, 2017 THRU MARCH 20, 2017. 7069656 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM MARCH 14, 2017 THRU MARCH 16, 2017. 7069654 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM MARCH 12, 2017 THRU MARCH 14, 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. THE PEURA (END USER RISK ANALYSIS) WAS PERFORMED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS OBSERVATIONS AND TESTING: RECEIVED 12 UNUSED Q-SYTE UNITS IN SEALED PACKAGES FROM THE LOT NUMBER 7116688. VISUAL/MICROSCOPIC EVALUATION: ALL SEPTUMS WERE MOLDED USING THE 32 CAVITY MOLD. NO PHYSICAL/MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE EXTERNAL AREAS OF THE Q-SYTE UNIT. WATER LEAK TEST: THE Q-SYTE UNIT WAS CONNECTED TO THE WATER LEAK TEST STATION AND TESTED IN THE UN-ACTUATE AND ACTUATED POSITIONS. NO LEAKAGE WAS OBSERVED IN THE UN-ACTUATED OR THE ACTUATED POSITIONS. SEPTUM COLUMN TEAR ASSESSMENT: NO DAMAGE (CUTS/TEARS) WAS OBSERVED ALONG THE COLUMN WALL. BOTTOM SEPTUM EVALUATION: THE RETURNED UNIT WAS DISASSEMBLED TO EVALUATE THE BOTTOM SEPTUM CONDITION. Q-SYTE UNIT 1 HAD A SMALL SLIT TEAR. NO PHYSICAL/MECHANICAL DAMAGE WAS OBSERVED TO THE SEPTUM BOTTOM DISK. THE SEPTUM SLIT CENTEREDNESS: THE SEPTUM SLIT CUT WAS NOT OFF CENTER ON ANY OF THE RETURNED Q-SYTE UNIT. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, THE RETURNED Q-SYTE UNITS PROVIDED FOR EVALUATION PERFORMED ACCORDING TO THEIR INTENDED PERFORMANCE SPECIFICATIONS. CONCLUSIONS: THE DEFECT LEAKAGE, AS STATED AS THE REPORTED CODE WAS NOT CONFIRMED NOR REPLICATED WITH THE RETURNED UNITS. THE RETURNED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, PER THE PIR. THE CUSTOMER¿S EXPERIENCE WAS NOT CONFIRMED BASED ON THE EVALUATION AND TESTING THAT WAS PERFORMED ON THE RETURNED UNITS. RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE ¿ THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO LEAKAGE. CORRECTIVE ACTION PROJECT: A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A QUARTERLY 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 · 1

    IT WAS REPORTED DURING USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE ARE MULTIPLE LEAKING ISSUES REPORTED WITH THIS REFERENCE, IT IS CONFIRMED BATCH 7116688 HAS BEEN PROVEN DEFECTIVE BUT OTHER BATCHES MAY BE OF CONCERNED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64849 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. 7116688 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other