BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 24380140 · Received February 18, 2026

    Report

    Report Number
    1119779-2026-00192
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 13, 2026
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NQX, NJR, OZN. G.4. THERE WERE MULTIPLE PMA/510K NUMBERS: K111860, K120138, K130470. 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: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6) HAD A FAULTY DOOR. CUSTOMER REPORTED PROBLEMS WITH THE DOOR, SPRING POPS OUT ON THE RIGHT SIDE WHENEVER THEY OPEN THE DOOR. SERVICE FOUND THE RIGHT-SIDE DOOR LATCH HAD COME OFF AND THE SCREWS HOLDING IT ALSO CAME OUT. THERE IS STICKY RESIDUE ALONG THE DOOR PATH ON BOTH SIDES WHERE THE LEFT AND RIGHT DOOR LATCHES ARE CAUSING FRICTION WHICH EVENTUALLY CAUSED THE HARDWARE TO COME LOOSE. SERVICE CLEANED THE RESIDUE OFF THE DOOR LATCHES, THEN REINSTALLED LATCHES AND VERIFIED THE DOOR IS FUNCTIONING AS INTENDED; INSTRUMENT WAS TURNED BACK OVER TO THE CUSTOMER FOR NORMAL USE. THIS COMPLAINT IS NOT A CONFIRMED FAILURE OF THE INSTRUMENT, AND THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF DEVICE HISTORY RECORD FOR THIS INSTRUMENT IS NOT REQUIRED AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALL OF THE INSTRUMENT. SERVICE HISTORY REVIEW WAS PERFORMED, AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE AVAILABLE FOR RETURNED MATERIAL INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX SYSTEM, BD MAX INSTRUMENT, THE DOOR WOULD NOT REMAIN OPEN. NO INJURIES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX SYSTEM, BD MAX INSTRUMENT, THE DOOR WOULD NOT REMAIN OPEN. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317997 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY OOI BECTON, DICKINSON & CO. (SPARKS) 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown