BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ STOPCOCK Q-SYTE

    MDR report key: 7575040 · Received June 6, 2018

    Report

    Report Number
    9610847-2018-00158
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 15, 2018
    Report Date
    July 13, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CUSTOMER REPORTED DISCONNECTION ISSUES; HOWEVER, BASED ON SAMPLE EVALUATION, THE WAY TO DETACH LUER LOCK COMPONENT IS OMITTING THE IFU RECOMMENDATIONS. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. PRODUCT IS FUNCTIONAL TESTED AND NO INCIDENTS WITH LUER LOCK REMOVALS HAVE BEEN REPORTED. PROCESS FMEA (B)(4) WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. ALWAYS REFER TO IFU FOR PRODUCT USAGE RECOMMENDATIONS. NO ACTIONS WILL BE TAKEN AT THIS TIME; HOWEVER WE WILL KEEP MONITORING THE MANUFACTURING PROCESS IN CASE ANY EMERGING TREND IS DETECTED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF OTHER WITH LOT #6090762 REGARDING ITEM #395245. INVESTIGATION CONCLUSION: BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOCK RING OF THE CONNECTION PART ON A BD¿ STOPCOCK Q-SYTE FELL OFF AFTER USE. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, SERIOUS 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 THE LOCK RING OF THE CONNECTION PART ON A BD¿ STOPCOCK Q-SYTE FELL OFF AFTER USE. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416434 BD¿ STOPCOCK Q-SYTE STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6090762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other