BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LOCKING N40-O

    MDR report key: 19298567 · Received May 13, 2024

    Report

    Report Number
    3003152976-2024-00284
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 24, 2024
    Report Date
    October 16, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    UDI-DI
    00382905150562
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION: MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, AN N40-O INJECTOR IS OBSERVED, HOWEVER, NO DAMAGE OR OTHER ISSUES CAN BE IDENTIFIED WITHIN THE PHOTO. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2308305, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. PRODUCT UNDERGOES A SERIES OF VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT THE MANUFACTURING PROCESS, INCLUDING VERIFICATION THAT ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. RETAINED SAMPLES OF LOT 2308305 WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS WERE OBSERVED, PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. IT IS IMPORTANT TO ENSURE ALL LUER CONNECTIONS ARE SECURELY TIGHTENED BEFORE USE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THEY HAD TWO DRUGS LEAK FROM THE CONNECTION BETWEEN THE END OF THE TUBING AND THE N-40 INJECTOR. VERBATIM: WE HAVE HAD A FEW ISSUES IN THE LAST WEEKS WITH SOME OF THE PHASEAL PRODUCTS AND I WANTED TO RUN THEM BY YOU TO SEE IF YOU HAVE COME ACROSS THEM BEFORE. WE HAD TWO DRUGS LEAK FROM THE CONNECTION BETWEEN THE END OF THE TUBING AND THE N-40 INJECTOR - BOTH WERE STILL CONNECTED TIGHTLY AND SPUN FREELY. (ONE WAS A 250ML BAG OF CARBOPLATIN AND THE OTHER WAS A WALKMED 150ML AMBULATOR PUMP BAG WHICH WAS NOTICED AT THE TIME OF DISCONNECT). THE FIRST EVENT OCCURRED ON 4/24/24 AND INVOLVED A SPILL OF CARBOPLATIN ATTACHED TO PRIMARY TUBING WITH AN N-40 INJECTOR. AT COMPLETION OF INFUSION, A LARGE PUDDLE OF DRUG WAS NOTICED BENEATH THE PUMP. WE WERE UNABLE TO DETERMINE EXACTLY WHERE THE LEAK CAME FROM BUT ARE ASSUMING IT WAS IN THE CONNECTION BETWEEN THE TUBING AND THE N-40. NEGATIVE OUTCOME: PATIENT DID NOT RECEIVE ENTIRE DOSE AND IT WAS NOT POSSIBLE TO DETERMINE HOW MUCH WAS LOST. THE TUBING ON THE CARBOPLATIN AND THE GEMCITABINE WAS A B BRAUN PRIMARY SET #352636 LOT 0061924868. THE TUBING ON THE FLUOROURACIL AMBULATORY PUMP WAS A WALKMED PUMP TUBING # 202747 LOT 21122502.

    Description of Event or Problem · 0

    MATERIAL # UNKNOWN LOT # UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THEY HAD TWO DRUGS LEAK FROM THE CONNECTION BETWEEN THE END OF THE TUBING AND THE N-40 INJECTOR. VERBATIM: WE HAVE HAD A FEW ISSUES IN THE LAST WEEKS WITH SOME OF THE PHASEAL PRODUCTS AND I WANTED TO RUN THEM BY YOU TO SEE IF YOU HAVE COME ACROSS THEM BEFORE. WE HAD TWO DRUGS LEAK FROM THE CONNECTION BETWEEN THE END OF THE TUBING AND THE N-40 INJECTOR - BOTH WERE STILL CONNECTED TIGHTLY AND SPUN FREELY. (ONE WAS A 250ML BAG OF CARBOPLATIN AND THE OTHER WAS A WALKMED 150ML AMBULATOR PUMP BAG WHICH WAS NOTICED AT THE TIME OF DISCONNECT). THE FIRST EVENT OCCURRED ON (B)(6) 2024 AND INVOLVED A SPILL OF CARBOPLATIN ATTACHED TO PRIMARY TUBING WITH AN N-40 INJECTOR. AT COMPLETION OF INFUSION, A LARGE PUDDLE OF DRUG WAS NOTICED BENEATH THE PUMP. WE WERE UNABLE TO DETERMINE EXACTLY WHERE THE LEAK CAME FROM BUT ARE ASSUMING IT WAS IN THE CONNECTION BETWEEN THE TUBING AND THE N-40. NEGATIVE OUTCOME: PATIENT DID NOT RECEIVE ENTIRE DOSE AND IT WAS NOT POSSIBLE TO DETERMINE HOW MUCH WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843242 INJECTOR LOCKING N40-O CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON 2308305 00382905150562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown