BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE

    MDR report key: 19775220 · Received July 18, 2024

    Report

    Report Number
    9610847-2024-00202
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 20, 2024
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 3093406. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD Q-SYTE CLOSED LEAKED ON (B)(6) 2024, A PATIENT IN THE ONCOLOGY DEPARTMENT UNDERWENT SURGERY FOR GASTRIC CANCER. THE NURSE INSTALLED AN INFUSION PORT FOR THE PATIENT AND USED AN INFUSION CONNECTOR FOR INFUSION TREATMENT. TEN MINUTES AFTER THE INFUSION BEGAN, THE PATIENT'S FAMILY SAID THAT THE PATIENT'S CLOTHES WERE SOAKED. THE NURSE CHECKED AND FOUND THAT THE INFUSION CONNECTOR WAS LEAKING. THE INFUSION CONNECTOR WAS IMMEDIATELY REPLACED TO ENSURE THAT THE PATIENT CONTINUED TO RECEIVE INFUSION TREATMENT. THIS CAUSED A WASTE OF THE PATIENT'S LIQUID MEDICINE AND PROLONGED THE PATIENT'S TREATMENT TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466826 BD Q-SYTE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3093406 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown