BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 21GA 2IN

    MDR report key: 12776524 · Received November 9, 2021

    Report

    Report Number
    3002682307-2021-00602
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 11, 2021
    Report Date
    January 10, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 210516. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, EMBEDDED YELLOW FOREIGN MATTER WAS OBSERVED WITHIN THE NEEDLE SHIELD. IT WAS CONCLUDED THAT THE FOREIGN MATERIAL MOST LIKELY RESULTED FROM RESIDUE LEFT FROM THE MAINTENANCE OF THE PRODUCT MOLDING MACHINERY.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE 21GA 2IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE FOUND A QUALITY ERROR CONCERNING. PER THE PHOTOS PROVIDED THERE WAS FOREIGN MATTER ON THE CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE 21GA 2IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE FOUND A QUALITY ERROR CONCERNING. PER THE PHOTOS PROVIDED THERE WAS FOREIGN MATTER ON THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676612 BD NEEDLE 21GA 2IN NEEDLE FMI BECTON DICKINSON, S.A. 210516

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown