BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ NEEDLE

    MDR report key: 16510757 · Received March 9, 2023

    Report

    Report Number
    2243072-2023-00353
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 15, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY 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. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND 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 AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ NEEDLE BROKE OFF INTO THE PATIENT'S ARM DURING THE B12 INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I USED ON OF YOUR NEEDLE TO INJECTION MONTHLY B 12 UPON INSERTION I INJECTED THE MEDICINE AND THE NEEDLE POPPED OFF SYRINGE INTO MY ARM UNDER THE SKIN I NOW HAVE TO HAVE NEEDLE SURGICALLY REMOVED FROM MY ARM WHAT IS THE FIX IT TO THIS BESIDE SURGERY IT SHOULD HAVE NOT POPPED OFF I TO MY ARM".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ NEEDLE BROKE OFF INTO THE PATIENT'S ARM DURING THE B12 INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I USED ONE OF YOUR NEEDLES TO INJECT MONTHLY B 12. UPON INSERTION, I INJECTED THE MEDICINE AND THE NEEDLE POPPED OFF SYRINGE INTO MY ARM, UNDER THE SKIN. I NOW HAVE TO HAVE NEEDLE SURGICALLY REMOVED FROM MY ARM. WHAT IS THE FIX IT TO THIS BESIDE SURGERY? IT SHOULD HAVE NOT POPPED OFF INTO MY ARM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550031 UNSPECIFIED BD¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown