BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8777734 · Received July 10, 2019

    Report

    Report Number
    9610847-2019-00456
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 19, 2019
    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: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS PROVIDED. BD RECEIVED ONE Q-SYTE UNIT WITH NO PACKAGING MATERIAL. THROUGH THE VISUAL/MICROSCOPIC EVALUATION, THE SEPTUM TOP DISK WAS UNGLUED FROM THE RIM AND ONE OF THE SIDES WAS PUSHED INTO THE ADAPTER. THERE WAS EVIDENCE OF ADHESIVE AND SEPTUM DEPOSITS VISIBLE AT THE RIM OF THE Q-SYTE UNIT. THIS EVIDENCE OF ADHESIVE IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED THAT THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE. THIS TYPE OF DAMAGE IS SOMETIMES CAUSED BY EXTERNAL FORCES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE PART OF THE SEPTUM AT Q SITE WAS SUNK IN THE HOUSING. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: A PART OF THE SEPTUM SANK IN THE HOUSING.

    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 DURING USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE PART OF THE SEPTUM AT Q SITE WAS SUNK IN THE HOUSING. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: A PART OF THE SEPTUM SANK IN THE HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572377 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8178586 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other