BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR N35-O

    MDR report key: 11032534 · Received December 17, 2020

    Report

    Report Number
    3003152976-2020-00572
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 19, 2020
    Report Date
    February 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/22/2020. H.6. INVESTIGATION: ONE PHOTO ALONG WITH ONE THOUSAND FIVE HUNDRED AND SEVEN INJECTOR SAMPLES WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON REVIEWING THE PHOTO, WHITE PARTICLES CAN BE OBSERVED ON THE SURFACE OF THE INJECTOR HUB. ALL SAMPLES RETURNED WERE INSPECTED USING MAGNIFICATION AND WHITE PARTICLES WERE FOUND ON ONE HUNDRED AND ONE OF THE INJECTORS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2002111, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS INSPECTED AND NO PARTICLES WERE OBSERVED ON ANY OF THE INJECTORS. STERILIZATION TESTING WAS PERFORMED AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. THE PRODUCT WAS SENT FOR CHARACTERIZATION TESTING AND THE PARTICLES WERE IDENTIFIED TO CONSIST OF TYVEK PAPER WHICH IS USED IN THE PACKAGING OF THIS PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A INJECTOR N35-O HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS A POWDERY LIKE RESIDUE WITHIN PACKAGING. EVENT DESCRIPTION STATES: A FINE POWDERY LIKE RESIDUE WITHIN THE PACKAGING AND ON THE N35-O. THIS WAS A SINGLE OCCURRENCE. ONLY OBSERVED ONCE FOR THIS LOT."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A INJECTOR N35-O HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS A POWDERY LIKE RESIDUE WITHIN PACKAGING. EVENT DESCRIPTION STATES: A FINE POWDERY LIKE RESIDUE WITHIN THE PACKAGING AND ON THE N35-O. THIS WAS A SINGLE OCCURRENCE. ONLY OBSERVED ONCE FOR THIS LOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496116 INJECTOR N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2002111

    Patients

    Seq Age Sex Outcome Treatment
    1