BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR N35-O

    MDR report key: 21399731 · Received February 18, 2025

    Report

    Report Number
    3003152976-2025-00055
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    UDI-DI
    00382905150708
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION, TRACES OF DRUG CAN BE OBSERVED NEAR THE HUB. THERE IS NO DAMAGE OR OTHER VISIBLE DEFECT THAT CAN BE IDENTIFIED WITHIN THE PHOTO TO INDICATE WHY A LEAK MAY HAVE OCCURRED. PRODUCT UNDERGOES A SERIES OF VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE ESTABLISHED 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

    MATERIAL#: UNKNOWN BATCH NUMBER#: UNKNOWN. WE HAD A PATIENT WITH A HOME PUMP WHO CAME FOR THEIR PUMP DC AND THE NURSE NOTED DRUG RESIDUE ON THE LINE NEAR THE BLUE COVER. I DO NOT HAVE ANY LOT/EXP INFORMATION FOR THE LINE OR PHASEAL. THE NURSE REPORTED THAT EVERYTHING WAS CONNECTED APPROPRIATELY. I CANNOT SAY FOR SURE WHETHER THIS IS A USER ERROR OR AN ISSUE WITH THE PHASEAL OR LINE. PLEASE LET ME KNOW YOUR THOUGHTS. I KNOW YOU HAVE ALREADY DONE REPEAT STAFF EDUCATION. PER RESPONSE ON (B)(6) 2025: 1. I DO NOT HAVE THE LOT EXPIRATION DATA SINCE IT WAS DISCOVERED 2 DAYS AFTER THE CONNECTION. THE PRODUCTS INVOLVED WERE BD PHASEAL OPTIMA INFUSION CLAMP M25-O (515085), OPTIMA CONNECTOR C35-O (515070), AND OPTIMA INJECTOR N35-O (515052). 2. NO PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59717 INJECTOR N35-O CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON UNKNOWN 00382905150708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown