BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 15142157 · Received August 1, 2022

    Report

    Report Number
    9610847-2022-00277
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 3, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 1243420, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED A Q-SYTE DEVICE THAT WAS ATTACHED ON A MISCELLANEOUS SYRINGE. THE IMAGE SHOWED A SYRINGE INSERTED IN THE Q-SYTE CONNECTION, HOWEVER, NO EVIDENCE OF FLUID FLOW ISSUES WERE OBSERVED AND WITHOUT A PHYSICAL SAMPLE FURTHER TESTING COULD NOT BE PERFORMED. THEREFORE, AFTER REVIEWING THE PROVIDED PHOTO THE ENGINEER DETERMINED THAT INSUFFICIENT EVIDENCE WAS PRESENT TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS COULD BE OBSERVED IN THE PROVIDED PHOTO A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS ISSUE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD Q-SYTE LUER ACCESS SPLIT SEPTUM THE SEPTUM WAS BLOCKED. THIS OCCURRED 9 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND THAT THE DIAPHRAGMS OF SEVERAL SEPTUM JOINTS COULD NOT BE COMPLETELY OPENED, RESULTING IN THE SITUATION OF INFUSION STAGNATION. AFTER REPLACING A CONNECTOR, IT NEED TO PUSH THE TIP OF THE SYRINGE TO THE END AND COMPLETELY OPEN IT BEFORE NORMAL INFUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD Q-SYTE LUER ACCESS SPLIT SEPTUM THE SEPTUM WAS BLOCKED. THIS OCCURRED 9 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND THAT THE DIAPHRAGMS OF SEVERAL SEPTUM JOINTS COULD NOT BE COMPLETELY OPENED, RESULTING IN THE SITUATION OF INFUSION STAGNATION. AFTER REPLACING A CONNECTOR, IT NEED TO PUSH THE TIP OF THE SYRINGE TO THE END AND COMPLETELY OPEN IT BEFORE NORMAL INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389724 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1243420 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown