BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7774543 · Received August 10, 2018

    Report

    Report Number
    9610847-2018-00254
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 22, 2018
    Report Date
    September 14, 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

    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 ONE USED Q-SYTE UNIT FROM THE FACILITY FOR EVALUATION. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SEPTUM PUSHED IN TO ADAPTER (Q-SYTE) WITH LOT #7209841 REGARDING ITEM #385100. THE DHR REVIEWS WERE PERFORMED ON THE SUB-ASSEMBLY LOT NUMBER: 7191539 WAS MANUFACTURED ON QFA LINE 2 STARTING ON JULY 29, 2017 THRU JULY 31, 2017. 7191967 WAS MANUFACTURED ON QFA LINE 3 STARTING ON JULY 18, 2017 THRU JULY 20, 2017. 7191968 WAS MANUFACTURED ON QFA LINE 3 STARTING ON JULY 20, 2017 THRU JULY 22, 2017. REVIEW OF THE DHR¿S REVEALED THAT ALL REQUIRED CHALLENGES SAMPLES, SET-UP AND IN-PROCESS TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE QUALITY SAMPLING PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. 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 EVALUATION: A SMALL PART OF THE SEPTA HAD BEEN PUSHED INTO THE Q-SYTE TOP BODY. THE RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS WERE EVIDENT ON THE RIM OF THE TOP BODY. THIS IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. ROOT CAUSE FOR THE INCIDENT IS INDETERMINATE. THE EVALUATION OF THE SEPTUM BEING PUSHED INTO ADAPTER LOCATION REVEALED EVIDENCE OF ADHESIVE AND SEPTUM DEPOSITS. THE OCCLUSION WAS FROM THE SEPTA BEING PUSHED INTO THE Q-SYTE TOP BODY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SEPTUM OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE PUSHED INTO THE ADAPTER BEFORE INFUSION. 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 THE SEPTUM OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE PUSHED INTO THE ADAPTER BEFORE INFUSION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612414 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7209841 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other