BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7137169 · Received December 21, 2017

    Report

    Report Number
    9610847-2017-00198
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 16, 2017
    Report Date
    January 24, 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

    INVESTIGATION SUMMARY: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, NO PHYSICAL OR MECHANICAL DAMAGES WERE OBSERVED ON ANY OF THE EXTERNAL AREAS OF THE Q-SYTE UNIT. A WATER LEAK TEST SHOWED NO LEAKAGE IN EITHER THE UNACTUATED OR ACTUATED POSITIONS. NO DAMAGES WERE OBSERVED TO THE COLUMN WALL UPON COMPLETION OF A SEPTUM COLUMN TEAR ASSESSMENT. THE RETURNED USED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO LEAKAGE, THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. LOT ANALYSIS DEVICE/BATCH HISTORY RECORD REVIEW: YES REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: AS THIS COMPLAINT WAS A MDR; -DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY LOT NUMBERS: 7040803 ¿ THIS LOT NUMBER WAS BUILT ON (B)(4), FROM FEBRUARY 11, 2017 THRU FEBRUARY 13, 2017 7041917 ¿ THIS LOT NUMBER WAS BUILT ON (B)(4), FROM FEBRUARY 11, 2017 THRU FEBRUARY 13, 2017 7041918 ¿ THIS LOT NUMBER WAS BUILT ON (B)(4), FROM FEBRUARY 13, 2017 THRU FEBRUARY 15, 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 ANALYSIS OBSERVATIONS AND TESTING: RECEIVED ONE USED Q-SYTE UNIT IN AN OPENED PACKAGE FROM THE LOT NUMBER 7086677. VISUAL/MICROSCOPIC EVALUATION: THE SEPTUM WAS MOLDED USING THE 16 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-ACTUATED 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. 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 UNIT PROVIDED FOR EVALUATION PERFORMED ACCORDING TO THEIR INTENDED PERFORMANCE SPECIFICATIONS. INVESTIGATION CONCLUSION: THE DEFECT LEAKAGE, AS STATED AS THE REPORTED CODE WAS NOT CONFIRMED WITH THE RETURNED UNIT. THE RETURNED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, PER THE PIR. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED UNIT. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO; THE CUSTOMER¿S EXPERIENCE WAS NOT CONFIRMED BASED ON THE EVALUATION AND TESTING THAT WAS PERFORMED ON THE RETURNED UNIT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE WAS NOT ACHIEVED WITH THE TESTING PERFORMED ON THE RETURNED UNIT. ROOT CAUSE RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE ¿ THE RETURNED USED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO LEAKAGE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. 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 LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916757 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LUER ACCESS SPLIT SEPTUM FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7086677 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other