BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27GA 1/2IN

    MDR report key: 10111302 · Received June 2, 2020

    Report

    Report Number
    3002682307-2020-00174
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 13, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 160924 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, A NEEDLE WITH THE SHIELD COMPONENT ON WAS OBSERVED. THROUGH VISUAL EXAMINATION, NO DEFECTS COULD BE IDENTIFIED WITH THE PRODUCT. BASED ON THE PROVIDED CUSTOMER FEEDBACK, NO CLINICAL CONSEQUENCES WERE IDENTIFIED AND THE PRODUCT WORKED PROPERLY. THE "BALL" AT THE BASED OF THE PRODUCT MENTIONED BY THE CUSTOMER, IS MOST LIKELY EPOXY; WHICH IS THE GLUE USED TO JOIN THE PRODUCT COMPONENTS TOGETHER AND IT IS PRESENT ON ALL OF THE NEEDLES PER STANDARD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "BALL" WAS FOUND AT THE BASE OF THE NEEDLE 27GA 1/2IN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "STAFF FOUND THAT THE NEEDLES WERE "LESS CONVENIENT" TO HANDLE, SMALLER WITH A "BALL" AT THE BASE. NO CLINICAL CONSEQUENCES ON THE PATIENT WERE NOTED, THE INJECTION OF THE PRODUCT WENT SMOOTHLY."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "BALL" WAS FOUND AT THE BASE OF THE NEEDLE 27GA 1/2IN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "STAFF FOUND THAT THE NEEDLES WERE "LESS CONVENIENT" TO HANDLE, SMALLER WITH A "BALL" AT THE BASE. NO CLINICAL CONSEQUENCES ON THE PATIENT WERE NOTED, THE INJECTION OF THE PRODUCT WENT SMOOTHLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571313 NEEDLE 27GA 1/2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 160924

    Patients

    Seq Age Sex Outcome Treatment
    1 Other