BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23GA 1-1/4IN

    MDR report key: 12405299 · Received September 1, 2021

    Report

    Report Number
    3002682307-2021-00453
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    June 17, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 210232. 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. AS SAMPLES HAVE NOT BEEN RECEIVED AT THIS TIME, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS WERE IDENTIFIED. BASED ON THE INVESTIGATIVE FINDINGS, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE NEEDLE 23GA 1-1/4IN, THE DEVICE EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON ONE CANNULA, WHITE DIRT WAS FOUND ON THE METAL CANNULA TIP IN THE SEALED PACKAGING. AS IT WAS NOT POSSIBLE TO DETERMINE WHERE THE DIRT CAME FROM AND STERILITY COULD NOT BE GUARANTEED, THE NEEDLES COULD NOT BE USED TO DRAW UP VACCINE. THE CANNULAS COULD NOT BE USED TO DRAW UP VACCINE.

    Additional Manufacturer Narrative · 1

    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 WHEN USING THE NEEDLE 23GA 1-1/4IN, THE DEVICE EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON ONE CANNULA, WHITE DIRT WAS FOUND ON THE METAL CANNULA TIP IN THE SEALED PACKAGING. AS IT WAS NOT POSSIBLE TO DETERMINE WHERE THE DIRT CAME FROM AND STERILITY COULD NOT BE GUARANTEED, THE NEEDLES COULD NOT BE USED TO DRAW UP VACCINE. THE CANNULAS COULD NOT BE USED TO DRAW UP VACCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307238 NEEDLE 23GA 1-1/4IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown