BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK MINI

    MDR report key: 23540494 · Received November 13, 2025

    Report

    Report Number
    2016493-2025-134425
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    September 9, 2022
    Report Date
    November 12, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING JANUARY 2022-DECEMBER 5, 2024, UNDER CAPA 10308384. THE LATE SUBMISSION OF THIS REPORT IS JUSTIFIED BY THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. SERIAL NUMBER IS NOT REPORTED IN COMPLAINT. PER SWI, (B)(4) COMPLAINT INVESTIGATION, IF SERIAL NUMBER NOT AVAILABLE, THEN COMPLAINT HISTORY REVIEW (CHR) IS NOT REQUIRED. NO VALID SERIAL NUMBER ATTACHED TO COMPLAINT RECORD. PER SWI (B)(4) COMPLAINT INVESTIGATION, IF NO SERIAL NUMBER IS PROVIDED, A DEVICE HISTORY REVIEW IS NOT REQUIRED. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SYSTEM USER UNABLE TO ISSUE THE MEDICATIONS. A TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER ON PATIENT PROFILE SETTINGS TO ADD PRIVILEGES TO ISSUE THE MEDICATIONS THEN ADVISED THE CUSTOMER TO LOG INTO MY Q LINK TO FIX THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDBANK MINI SYSTEM USER UNABLE TO ISSUE THE MEDICATIONS BECAUSE ADD ITEMS BUTTON WAS GREYED OUT WHEN THE USER TRIED TO ISSUE MEDS FOR THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929182 BD PYXIS¿ MEDBANK MINI AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown