BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA Q-SYTE WHT

    MDR report key: 8351876 · Received February 19, 2019

    Report

    Report Number
    9610847-2019-00175
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    January 18, 2019
    Report Date
    March 12, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    UDI-DI
    00382903945016
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8121553. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY THE SAMPLE SUBMITTED BY YOUR FACILITY WAS REVIEWED, OUR QUALITY ENGINEERS WERE ABLE TO IDENTIFY SILICON RESIDUE ON PORT A, INDICATING THAT THE ROOT CAUSE EXCESS APPLICATION OF SILICON TO THE DEVICE. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CUSTOMER REPORTED DETACHED LOCK RING ISSUES; SAMPLE HAVE BEEN FUNCTIONAL TESTED AND VISUAL INSPECTED SHOWING PROBLEMS (DISCONNECTION AND SILICONE PRESENCE); AFTER SAMPLE EVALUATION BY THE ENGINEERING TEAM, THE POTENTIAL CAUSES FOR LUER LOCK DETACHMENT IS A WRONG ASSEMBLY OR THE SILICON PRESENCE ON PORT A; UNFORTUNATELY, THE PACKAGE WAS OPENED AND SAMPLE HANDLED PRIOR INVESTIGATION TO DISCARD ONE OF THE TWO POTENTIAL FAILURE MODES. REVIEWING MAINTENANCE RECORDS FOR EQUIPMENT UNDER INVESTIGATION, NOTHING EXTRAORDINARY WAS REPORTED AND NO REPAIRS PERFORMED DURING LOT PRODUCTION ON STATIONS 03 AND 06. QUALITY RECORDS (INTERNAL REJECTS) HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED. ISSUE PREVIOUSLY REPORTED IN CUSTOMER COMPLAINTS BUT ONLY 3 TIMES CONFIRMED FOR CONNECTA PRODUCT FAMILY, HOWEVER, ONLY TWO CUSTOMER COMPLAINTS WERE CONFIRMED WITH A PROBABLE ROOT CAUSE OF SILICONE PRESENCE (DURING 2013-2018). THE COMPLAINT RATE REMAINS HISTORICALLY LOW LEVELS AS OBSERVED ON RECORDS WHICH MEANS PRETTY LOW OCCURRENCE. PROCESS FMEA RM5895 AND EURAP2053001 WERE REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE IS ASSOCIATED TO STATION 03 AND STATION 06.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONNECTA Q-SYTE WHT HAD A DETACHED LOCK-RING WHEN THE PACKAGE WAS OPENED.

    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 A CONNECTA Q-SYTE WHT HAD A DETACHED LOCK-RING WHEN THE PACKAGE WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143024 CONNECTA Q-SYTE WHT STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8121553 00382903945016

    Patients

    Seq Age Sex Outcome Treatment
    1 Other