BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 9630056 · Received January 24, 2020

    Report

    Report Number
    9610847-2020-00016
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 27, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    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: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE Q-SYTE UNIT WITHOUT THE DUST CAP INSIDE OF A PLASTIC BAG. ALSO RETURNED WITH THE UNIT WAS A FOLDED DISPENSER FROM LOT NUMBER 9122571. IN ADDITION, THREE PHOTOGRAPHS WERE ALSO SUBMITTED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. THROUGH THE VISUAL EXAMINATION, A STRAND OF HAIR WAS OBSERVED ON THE Q-SYTE PROTRUDING FROM THE AREA BETWEEN THE TOP AND BOTTOM BODY. THIS WAS THE PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO HUMAN ERROR IN THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "A HAIR GOT CAUGHT IN THE Q-SYTE."

    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 FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "A HAIR GOT CAUGHT IN THE Q-SYTE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93088 BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 9122571 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other