BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE

    MDR report key: 17183373 · Received June 22, 2023

    Report

    Report Number
    3002682307-2023-00166
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    May 26, 2023
    Report Date
    July 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305146 AND LOT NUMBER 0070466. 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 WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION BY OUR INVESTIGATIVE TEAM. THE RETAINED SAMPLES WERE VISUALLY EXAMINED AND NO SIGNS OF DEFECT COULD BE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HALF THE TIP OF A 23G BLUE HYPODERMIC NEEDLE WAS MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HALF THE TIP OF A 23G BLUE HYPODERMIC NEEDLE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217878 BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 0070466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention