BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7793216 · Received August 17, 2018

    Report

    Report Number
    9610847-2018-00264
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    July 26, 2018
    Report Date
    September 18, 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
    MY
    Reporter Occupation
    OTHER

    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: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: RECEIVED USED Q-SYTE UNIT IN AN OPENED PACKAGE. DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY LOT NUMBERS: 7220547 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM AUGUST 14, 2017 THRU AUGUST 14, 2017. REVIEW OF DHR¿S REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED ONE NON-RELATED QN WAS INITIATED DURING THE BUILD OF ANY OF THE LOT THAT WOULD NOT IMPACT THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PR. 7234822 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM AUGUST 24, 2017 THRU AUGUST 26, 2017. REVIEW OF DHR¿S REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF ANY OF THE LOT NUMBERS. 7234825 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM AUGUST 26, 2017 THRU AUGUST 28, 2017. REVIEW OF DHR¿S REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF ANY OF THE LOT NUMBERS. VISUAL/MICROSCOPIC EXAMINATION: OBSERVED SLIT TEARS ON THE SEPTUM TOP DISK. WATER LEAK TEST: Q-SYTE WAS LEAK TESTED IN THE ACTUATED AND UN-ACTUATED POSITIONS; LEAKAGE WAS NOT CONFIRMED IN THE ACTUATED OR UN-ACTUATED POSITIONS. SEPTUM COLUMN TEAR ASSESSMENT: NO DAMAGE (TEAR) OBSERVED ALONG THE COLUMN WALL. BOTTOM SEPTUM EVALUATION: THE RETURNED UNIT WAS DISASSEMBLED TO EVALUATE THE BOTTOM SEPTUM CONDITION. OBSERVED A SLIT TEAR ON THE SEPTUM BOTTOM DISK. PHOTOS OF THE SLIT CENTEREDNESS: THE SEPTUM SLIT CUT WAS NOT OFF CENTER. 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, PER THE PIR. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED UNIT. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BLOOD WAS FOUND LEAKING THROUGH Q-SYTE SILICONE SEPTUM. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    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 DURING USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BLOOD WAS FOUND LEAKING THROUGH Q-SYTE SILICONE SEPTUM. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636727 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7242781 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other