BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 11829057 · Received May 14, 2021

    Report

    Report Number
    9610847-2021-00214
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 16, 2021
    Report Date
    June 18, 2021
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT Q-SYTE CLOSED LUER ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED SEPTUM OF Q-SYTE. THE CUSTOMER REPORTED AS FOLLOWS: INSERTION INTO THE SEPTUM OF Q-SYTE WAS PERFORMED TWICE DAILY. TWO WEEKS AFTER THE START OF ITS USE, ONE SIDE OF THE SEPTUM WAS DAMAGED LIKE CHIPPED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT Q-SYTE CLOSED LUER ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED SEPTUM OF Q-SYTE. THE CUSTOMER REPORTED AS FOLLOWS: INSERTION INTO THE SEPTUM OF Q-SYTE WAS PERFORMED TWICE DAILY. TWO WEEKS AFTER THE START OF ITS USE, ONE SIDE OF THE SEPTUM WAS DAMAGED LIKE CHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723720 Q-SYTE CLOSED LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1