BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21GA 2IN

    MDR report key: 9563540 · Received January 8, 2020

    Report

    Report Number
    3002682307-2019-00711
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 17, 2019
    Report Date
    February 7, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG 301155 LOT 181216 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF ONE OF THE PHOTOS SHOWS A BLACK PARTICLE INSIDE THE SEALED PACKAGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. UNFORTUNATELY, WITHOUT AN ACTUAL SAMPLE, BD WAS UNABLE TO CHARACTERIZE THE NATURE OF THE DETECTED BLACK PARTICLE ENCOUNTERED IN THE SEALED PACKAGE. IT IS SUSPECTED THAT THE PARTICLE MAY BE SOME RESIDUE OF THE PACKAGING MACHINE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A NEEDLE 21GA 2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THERE IS A BLACK PARTICLE IN A NEEDLE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A NEEDLE 21GA 2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THERE IS A BLACK PARTICLE IN A NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30191 NEEDLE 21GA 2IN NEEDLE FMI BECTON DICKINSON, S.A. 181216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other