BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR N35-O

    MDR report key: 18920818 · Received March 18, 2024

    Report

    Report Number
    3003152976-2024-00165
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 28, 2024
    Report Date
    August 26, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Additional Manufacturer Narrative · 0

    THREE PHOTO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PRODUCT, WHITE PARTICLES WERE OBSERVED ON THE SURFACE OF THE INJECTOR. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED FOR LOT 2212307, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED PROBLEM WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE INJECTORS WERE THOROUGHLY INSPECTED AND NO PARTICLES OR OTHER FOREIGN MATTER WAS OBSERVED ON ANY OF THE DEVICES. EVALUATIONS WERE CONDUCTED USING SEVERAL LOTS FROM VARIOUS PHASEAL OPTIMA PRODUCTS, IN ATTEMPT TO REPLICATE THE PARTICLES THAT WERE OBSERVED, USING AN ALCOHOL WIPE AND A STANDARD DRY WIPE TO CLEAN THE CONTAINER PRIOR TO USE. IT WAS OBSERVED THAT WHEN AN ALCOHOL WIPE WAS USED AND MORE FORCE WAS APPLIED WHEN CLEANING THE CONTAINER, PARTICLE GENERATION DID OCCUR. STERILIZATION TESTS WERE REVIEWED FOR THE REPORTED LOT AND THE RESULTS WERE VERIFIED TO BE WITHIN SPECIFICATIONS. THE MANUFACTURING OF THIS PRODUCT TAKES PLACE IN A CLEAN ROOM THAT IS MAINTAINED UNDER POSITIVE PRESSURE TO REDUCE THE POSSIBILITY OF FOREIGN MATTER. A REVIEW OF THE MANUFACTURING RECORDS ESTABLISHED THAT ALL CLEANING OF THE PACKAGING LINES WAS PERFORMED IN ACCORDANCE WITH PROCEDURE. WHILE WE HAVE SEEN PARTICLE GENERATION WHEN THE PRODUCT PACKAGE IS WIPED VIGOROUSLY BEFORE USE, WE CANNOT STATE THAT TO BE TRUE FOR THE INCIDENT REPORTED, THEREFORE WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    MATERIALS#: 515052 BATCH#: 2212306 IT WAS REPORTED BY THE CUSTOMER THAT WHITE POWDER FOUND ON INJECTOR AGAIN. VERBATIM: WHITE POWDER FOUND ON INJECTOR AGAIN. PLEASE PROVIDE AN UPDATE ON PREVIOUS PIR. PICTURES WERE PROVIDED FOR SAME INCIDENT THEN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162312 INJECTOR N35-O CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON 2212307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown