BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE CLOSED LUER ACCESS PORT - BNS

    MDR report key: 8744420 · Received June 28, 2019

    Report

    Report Number
    1710034-2019-00688
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 7, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K013621
    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 PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT 5 PHOTOS WERE PROVIDED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE REPORTED LOT WAS UNKNOWN. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND DETERMINED THAT THE Q-SYTE WAS NOT DISCOLORED BUT THAT THE ATTACHED EXTENSION TUBING AND MALE LUER WERE DISCOLORED. BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DISCOLORATION WAS OBSERVED WITH THE Q-SYTE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AND WITHOUT THE PHYSICAL SAMPLE NO FURTHER TESTING COULD BE PERFORMED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISCOLORATION OCCURRED AFTER USE WITH A Q-SYTE CLOSED LUER ACCESS PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CONNECTION OF Q-SYTE AND EXTENTION TUBE WAS DISCOLORED."

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 DISCOLORATION OCCURRED AFTER USE WITH A Q-SYTE CLOSED LUER ACCESS PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CONNECTION OF Q-SYTE AND EXTENTION TUBE WAS DISCOLORED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536565 Q-SYTE CLOSED LUER ACCESS PORT - BNS INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other