BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BD SYRINGE

    MDR report key: 19350293 · Received May 20, 2024

    Report

    Report Number
    2243072-2024-00634
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    January 30, 2024
    Report Date
    May 2, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WITH DEVICE EVALUATION. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    Description of Event or Problem · 0

    MATERIAL# UNKNOWN BATCH# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT WHEN IT WAS ATTACHED TO THE VIAL, THE MEDICATION STARTED LEAKING AROUND THE STOPPER AND THE PRODUCT COULD NOT BE USED¿ VERBATIM RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS LETTER IS TO NOTIFY YOU OF A RECENT FIELD PRODUCT COMPLAINT THAT EAGLE PHARMACEUTICALS INC. (EAGLE) RECEIVED REGARDING OUR ONCOLOGY PRODUCT BENDEKA® (BENDAMUSTINE HYDROCHLORIDE INJECTION 100 MG / 4 ML, 25 MG / ML) AND DIFFICULT TO WITHDRAW SOLUTION. THIS COMPLAINT, (B)(4) (PR # (B)(4) ) WAS ASSOCIATED WITH A BD CLOSED SYSTEM TRANSFER DEVICE (CSTD), THE TEXIUM¿ SYSTEM. THE COMPLAINANT, A PHARMACIST, REPORTED THAT THEY USED A CSTD TO PUNCTURE THE STOPPER OF THE VIAL, AND ¿WHEN IT WAS ATTACHED TO THE VIAL, THE MEDICATION STARTED LEAKING AROUND THE STOPPER AND THE PRODUCT COULD NOT BE USED¿. THE CSTD USED TO WITHDRAW THE BENDEKA SOLUTION FROM THE VIAL WAS THE TEXIUM SYSTEM MANUFACTURED BY BD (PART AND MODEL # NOT AVAILABLE). A PRODUCT COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN; NEITHER ARE PHOTOGRAPHS. SINCE BENDEKA WAS MARKETED IN THE UNITED STATES IN JANUARY 2016, WE HAVE RECEIVED A FEW COMPLAINTS OF ¿DIFFICULT TO WITHDRAW¿ OR ¿STOPPER LEAKAGE¿ WITH CSTDS BY DIFFERENT MANUFACTURERS. WE NOTIFY THE RESPECTIVE DEVICE MANUFACTURERS REGARDING THESE COMPLAINTS. EAGLE INVESTIGATED THIS MARKET COMPLAINT OF BENDEKA AND DIFFICULT TO WITHDRAW SOLUTION FROM THE VIAL WITH THE USE OF BDS DEVICE, TEXIUM SYSTEM, BY PERFORMING MANUFACTURING SITE REVIEWS. ADDITIONAL INFORMATION: WHAT IS THE DATE OF EVENT? 01/30/2024.   2. PLEASE SHARE THE MATERIAL & LOT NUMBER? UNKNOWN. NOT AVAILABLE. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NOT ADMINISTERED TO A PATIENT. ONE VIAL OF BENDEKA® WAS INVOLVED, WHICH WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856784 UNKNOWN BD SYRINGE SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown