BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR N35-O

    MDR report key: 23036757 · Received September 12, 2025

    Report

    Report Number
    3003152976-2025-00498
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    September 2, 2025
    Report Date
    April 10, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: FIVE UNUSED INJECTORS AND TWO SYRINGES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DAMAGE OR DEFECTS CAN BE OBSERVED ON THE OPTIMA INJECTORS OR LUER THREADING THAT MAY HAVE LEAD TO THE REPORTED CONNECTION ISSUES. FUNCTIONAL TESTING WAS PERFORMED AND VERIFIED THE INJECTOR COULD NOT FULLY LUER WITH THE RETURNED SYRINGES. DIMENSIONAL TESTING CONFIRMED THAT THE INJECTOR¿S LUER MET ALL REQUIRED SPECIFICATIONS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2412305, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS CONCERN. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. DIMENSIONAL TESTING WAS PERFORMED, INCLUDING THE LUER THREAD, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. PRODUCT UNDERGOES A SERIES OF VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT THE MANUFACTURING PROCESS. RECORDS WERE REVIEWED FOR THE SUSPECTED LOT AND NO ISSUES RELATED TO THIS FAILURE WERE IDENTIFIED. BASED ON THE EVALUATION OF THE SAMPLE, WE WERE UNABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE INJECTOR AT THIS TIME. THE FINDINGS SUGGEST THAT THE SYRINGE IS THE LIKELY SOURCE OF THE ISSUE OBSERVED. 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.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE OPTIMA UNLURES. ENTRY DESCRIPTION: BD PHASEAL OPTIMA SYRINGE TOP - REF: 515052, LOT: 2412305. WHEN THE PHARMACISTS ARE LUERING AN OPTIMA INJECTOR ONTO ANY SYRINGE (BD 50ML SYRINGE - REF: 309653 LOT: 5142409, BD 10ML SYRINGE - REF: 302995, LOT: 5037755, BD 20ML SYRINGE - REF: 302830 LOT: 5120041), THEY ARE FINDING IT HARD TO LUER ON COMPLETELY AND FINDING THAT THE OPTIMA PIECE UNLUERES ON ITS OWN SLIGHTLY BEFORE APPLYING ANY PRESSURE TO THE PLUNGER. ALSO, WHEN THEY DO APPLY DOWNWARD PRESSURE TO THE SYRINGE, IT IS ALSO A POINT WHERE THE LUERED CONNECTION HAS COME COMPLETELY UNLUERED. THEY ATTEMPTED TO REPLICATE THE CHALLENGE WITH OTHER MALE LUER DEVICES ONTO THE SAME FEMALE LUER TIP OF THE SYRINGE AND THIS DID NOT HAPPEN, WHICH SUGGESTS THAT IT IS ISOLATED TO THE OPTIMA INJECTOR. FOR YOUR INVESTIGATION, THEY ALSO WOULD LIKE TO PROVIDE THE THREE SYRINGES THEY TRIED TO LUER ON TO THE OPTIMA INJECTOR FOR YOUR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312961 INJECTOR N35-O CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON, S.A. 2412305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown