BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE VIAL ACCESS ADAPTER

    MDR report key: 21385272 · Received February 14, 2025

    Report

    Report Number
    1710034-2025-00214
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 26, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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 385108 AND LOT NUMBER 4152430 . 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE VIAL ACCESS ADAPTER LEAKED. IT WAS REPORTED BY CUSTOMER THAT THEY HAD MEDICATION LEAK DUE TO A FAULTY Q STYLE ADAPTER. RCC RECEIVED A COMPLAINT VIA EMAIL. PT REPORTS SHE HAD MEDICATION LEAK DUE TO A FAULTY Q STYLE ADAPTER. NO MISSED DOSE/ADVERSE EVENT REPORTED DUE TO DEFECTIVE DEVICE. UNKNOWN IF DEFECTIVE DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638377 BD Q-SYTE VIAL ACCESS ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female