BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18GA 2IN

    MDR report key: 9520794 · Received December 26, 2019

    Report

    Report Number
    3002682307-2019-00688
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 10, 2019
    Report Date
    January 22, 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
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 301900 LOT 180423 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO SHOWS A HAIR ON THE NEEDLE, NOT ON THE CANNULA OR FLUID PATH BUT IN THE PIVOT. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. A HAIR WAS LOST DUE TO A FAILURE TO PERFORM GOOD MANUFACTURING PROCEDURE PRACTICES BY THE BD SITE OPERATOR. BD HAS INITIATED A DEEP COMPREHENSIVE PROGRAM WHICH INCLUDES ALL ASPECTS OF OUR PRODUCTION OPERATIONS, INCLUDING THE MANUFACTURING ENVIRONMENTS, EQUIPMENT AND PROCESSES IN ORDER TO ELIMINATE THE WIDER RANGE OF POTENTIAL SOURCES OF "FOREIGN MATTER". THE MAIN GOAL OF THESE PROGRAMS ARE TO RAISE AWARENESS ON THE PRODUCTION FLOOR IN ORDER TO PAY MORE ATTENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE 18GA 2IN THERE WAS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: PRESENCE OF A HAIR IN THE NEEDLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE 18GA 2IN THERE WAS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: PRESENCE OF A HAIR IN THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316922 NEEDLE 18GA 2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 180423

    Patients

    Seq Age Sex Outcome Treatment
    1 Other