BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8019960 · Received October 30, 2018

    Report

    Report Number
    9610847-2018-00353
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 11, 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

    INVESTIGATION SUMMARY: RECEIVED ONE Q-SYTE ASSEMBLY WITHIN AN OPEN PACKAGE FROM LOT NUMBER 7327641. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAK FROM TOP OF SEPTUM (Q-SYTE) WITH LOT #7327641 REGARDING ITEM #385100. DHR REVIEW: 7335967 ¿ A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 2 FROM 6DEC17 THROUGH 8DEC17. 7331828 ¿ A TOTAL OF 180,000 UNITS WERE MANUFACTURED ON QFA LINE 3 FROM 6DEC17 THROUGH 8DEC17. 7335969 ¿ A TOTAL OF 216,000 UNITS WERE MANUFACTURED ON QFA LINE 4 FROM 8DEC17 THROUGH 10DEC17. ALL CHALLENGE, SET-UP AND IN PROCESS SAMPLES AND TESTING WERE PERFORMED IN ACCORDANCE WITH QUALITY CONTROL PLAN ALL PASSED PER SPECIFICATIONS. VISUAL/MICROSCOPIC EXAMINATION: DAMAGE (TEAR) WAS OBSERVED ON THE SLIT OF THE TOP SEPTUM DISK. DAMAGE (TEAR) WAS OBSERVED ON THE COLUMN WALL. DAMAGE (TEAR) WAS OBSERVED ON THE SLIT OF THE BOTTOM SEPTUM DISK (DISSECTED AFTER WATER-LEAK TEST). WATER LEAK TEST (MM-110): ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END THE Q-SYTE UNIT AND PERFORMED THE TEST. NO LEAKAGE WAS OBSERVED ON THE UNACTUATED POSITION. LEAKAGE WAS OBSERVED ON THE ACTUATED POSITION, THE UNIT LEAKED THROUGH THE COLUMN TEAR AND OUT THE VENT HOLE. INDETERMINATE - A DEFINITE SOURCE THAT CAUSED DAMAGE TO THE TOP AND BOTTOM SLITS AND THE COLUMN TEAR (WHICH COULD HAVE CONTRIBUTED TO THE LEAKAGE) COULD NOT BE ESTABLISHED. THE FAILURE MODES NORMALLY ATTRIBUTED TO THESE TYPES OF DAMAGE ARE INCORRECT USAGE OR EXCESSIVE ACTUATIONS. CONCLUSION(S): 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 USING OF A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, THERE WAS LEAK FROM TOP OF SEPTUM DURING THE FIRST CONNECTION. THERE WAS NO MEDICAL INTERVENTIONS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 USING OF A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, THERE WAS LEAK FROM TOP OF SEPTUM DURING THE FIRST CONNECTION. THERE WAS NO MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860927 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7327641 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other