BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE¿ BI-EXTENSION SET

    MDR report key: 14135538 · Received April 18, 2022

    Report

    Report Number
    9610847-2022-00143
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 22, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50382903851633
    PMA / PMN Number
    K142527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 1 SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKS AT CONNECTION TO ANOTHER SET WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLE. NO ABNORMAL CONDITIONS OR DAMAGES WERE OBSERVED ON THE SAMPLE. THE SAMPLE ALSO UNDERWENT OUR INTERNAL LEAKAGE TESTING AND NO SIGNS OF LEAKAGE WERE OBSERVED. A MANUFACTURING ROOT CAUSE WAS NOT DETERMINED SINCE THE REPORTED FAILURE WAS NOT CONFIRMED. 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 3 BD Q-SYTE¿ BI-EXTENSION SETS HAD LEAKAGE ISSUES, RESULTING IN A SECOND CHEMO DOSE BEING NECESSARY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BD Q-SYTE BI-EXTENSION SET WAS LEAKING (THREE INCIDENCES) WHILE CONNECTED TO A PORT NEEDLE (POLYFLON MAKE FROM COMPETITOR)THIS HAPPENED WHILE INFUSING CHEMO USING AN INFUSION PUMP."

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BD Q-SYTE¿ BI-EXTENSION SETS HAD LEAKAGE ISSUES, RESULTING IN A SECOND CHEMO DOSE BEING NECESSARY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BD Q-SYTE BI-EXTENSION SET WAS LEAKING (THREE INCIDENCES) WHILE CONNECTED TO A PORT NEEDLE (POLYFLON MAKE FROM COMPETITOR)THIS HAPPENED WHILE INFUSING CHEMO USING AN INFUSION PUMP"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605868 BD Q-SYTE¿ BI-EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385163 1193264 50382903851633

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other