BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7802369 · Received August 21, 2018

    Report

    Report Number
    9610847-2018-00279
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    August 1, 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
    CH
    Reporter Occupation
    NURSE

    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: B.2. EVENT ATTRIBUTED TO: OTHER, D.8. DEVICE SINGLE USE?: NO, H.3. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: RECEIVED ONE Q-SYTE ASSEMBLY WITHIN AN OPEN PACKAGE FROM LOT NUMBER 7242779. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #7242779 REGARDING ITEM #385100. DHR REVIEW: 7227575 WAS BUILT ON QFA LINE #3, FROM 18AUG2017 THRU 20AUG2017 FOR THE QUANTITY OF (B)(4). 7227576 WAS BUILT ON QFA LINE #3, FROM 20AUG2017 THRU 21AUG2017 FOR THE QUANTITY OF (B)(4). 7234812 WAS BUILT ON QFA LINE #2, FROM 26AUG2017 THRU 28AUG2017 FOR THE QUANTITY OF (B)(4). ALL CHALLENGES, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. A BROWN/REDDISH PARTICLE (ABOUT 4MM.) WAS OBSERVED WITHIN THE Q-SYTE ASSEMBLY BETWEEN THE BOTTOM SEPTUM DISK AND THE TOP Q-SYTE BODY. UPON DISSECTION OF THE ASSEMBLY IT WAS OBSERVED THE PARTICLE WAS LOOSE (NOT BONDED) WITHIN THE UNIT. PROBABLE ROOT CAUSE IS RELATED TO MANUFACTURING/MOLDING PROCESS. ALTHOUGH THE DEFINITE SOURCE OF THE PARTICLE COULD NOT BE IDENTIFIED IT IS KNOWN THAT WAS INTRODUCED DURING THE MOLDING PROCESS OF THE PRODUCT. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. 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. NOTE: 5S CLEANING IS PERFORMED BY EACH SHIFT TO MINIMIZE THE POTENTIAL FOR INTRODUCING FOREIGN MATTER TO THE PRODUCT. POTENTIAL NONCONFORMANCE INCLUDES ANY VIOLATIONS OF THE GMPS INCLUDING QS3-0035, WHICH DEFINES THE BD GOWNING POLICY. 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 BLACK FOREIGN MATTER WAS FOUND ON THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. 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 BLACK FOREIGN MATTER WAS FOUND ON THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641477 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7242779 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other