BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21GA 2IN

    MDR report key: 12501304 · Received September 20, 2021

    Report

    Report Number
    3002682307-2021-00499
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 23, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: 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, BOTH PICTURE SAMPLES AND THREE BLISTER PACKAGE STRIPS OF FIVE NEEDLES EACH WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE BLISTER PACKAGES WERE UNOPENED. ONE OF THE NEEDLES PRESENTED A SHIELD COMPONENT WITH FOREIGN MATTER EMBEDDED WITHIN IT. THE FOREIGN MATTER WAS YELLOWISH IN COLOR. UPON FURTHER EXAMINATION, THE FOREIGN MATTER WAS IDENTIFIED AS RESIDUE FROM THE AUXILIAR COMPONENTS OF THE MOLDING MACHINE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED NEEDLE 21GA 2IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "THE COMPLAINT CONCERNS THE FACT THAT THERE IS SOMETHING YELLOW IN THE SLEEVE AND AT THE END IT HAS TURNED BLACK."

    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 NEEDLE 21GA 2IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE COMPLAINT CONCERNS THE FACT THAT THERE IS SOMETHING YELLOW IN THE SLEEVE AND AT THE END IT HAS TURNED BLACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396161 NEEDLE 21GA 2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210516

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown