BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17870223 · Received October 4, 2023

    Report

    Report Number
    2243072-2023-01783
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 7, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND/OR LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. 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 · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WERE DEFECTIVE. THE FOLLOWING WAS RECEIVED FROM THE FOLLOWING REPORTER: ISSUE OCCURRED WITH TWO DIFFERENT PHARMACIST. ISSUE OCCURRED TODAY TWICE 11-SEP-2023. ISSUE PREVIOUSLY OCCURRED AROUND TWO WEEKS AGO AS WELL BUT NOT SURE HOW MANY TOTAL OCCURRENCES FROM THEN. NO PATIENT HARM OR ADVERSE EVENTS BEING REPORTED. PHARMACIST ADVISED THAT SHE KNOWS THE ISSUES OCCURRED AT OTHER LOCATIONS BUT DOES NOT HAVE THOSE DETAILS AND SHE WILL LET US KNOW IF SHE DOES GET THEM. SHE WILL ENCOURAGE HER COLLEAGUES TO CALL IN WHEN THEY HAVE ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WERE DEFECTIVE. THE FOLLOWING WAS RECEIVED FROM THE FOLLOWING REPORTER: ISSUE OCCURRED WITH TWO DIFFERENT PHARMACIST. ISSUE OCCURRED TODAY TWICE (B)(6) 2023. ISSUE PREVIOUSLY OCCURRED AROUND TWO WEEKS AGO AS WELL BUT NOT SURE HOW MANY TOTAL OCCURRENCES FROM THEN. NO PATIENT HARM OR ADVERSE EVENTS BEING REPORTED. PHARMACIST ADVISED THAT SHE KNOWS THE ISSUES OCCURRED AT OTHER LOCATIONS BUT DOES NOT HAVE THOSE DETAILS AND SHE WILL LET US KNOW IF SHE DOES GET THEM. SHE WILL ENCOURAGE HER COLLEAGUES TO CALL IN WHEN THEY HAVE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104667 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown