BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 19243922 · Received May 3, 2024

    Report

    Report Number
    3002682307-2024-00092
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 8, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903004003
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D. THE LOT NUMBER 220618 PROVIDED CANNOT BE VERIFIED IN ASSOCIATION WITH THE REPORTED MATERIAL NUMBER. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A REPORT FOR NEEDLE SEPARATION FROM HUB WAS RECEIVED WITH THE MATERIAL INFORMATION OF MATERIAL 304000 AND BATCH 220618. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED TO OUR QUALITY INVESTIGATIVE TEAM. UPON EXAMINATION OF THE RETURNED SAMPLE, IT WAS IDENTIFIED THAT THE MATERIAL DID NOT ALIGN WITH THE BD MICROLANE PRODUCT LINE. THE RETURNED SAMPLE DID NOT BELONG TO MATERIAL 304000 AND BATCH 220618, NOR DID IT ALIGN WITH THE BD MICROLANCE NEEDLE PRODUCT LINE IN GENERAL. THE NEEDLE SAMPLE APPEARS TO BELONG TO ANOTHER COMPANY BASED ON A THOROUGH ANALYSIS OF THE PRODUCT DESIGN COMPONENTS. BASED ON THIS CONCLUSION, NO FURTHER INVESTIGATION RESULTS COULD BY CONCLUDED BY BD FOR THIS REPORTED INCIDENT. CORRECTION: CANCEL MDR. THIS IS NOT A BD PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES NEEDLE PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE USED TO INFLITRATE LOCAL ANAESTHETIC FOR INSERTION OF ARTERIAL LINE ON R WRIST W/ U/S GUIDANCE. NEEDLE MOVED TO REPOSITION AND NOTED NEEDLE WAS NO LONGER ATTACHED TO PLASTIC HUB. NEEDLE VISUALISED IN THE SUB-Q TISSUES W/ U/S AND WITH X-RAY. PATIENT REQUIRED SURGICAL EXPLORATION UNDER GENERAL ANAESTHESIA OF HER WRIST TO REMOVE NEEDLE, IN ADDITION TO HER INTENDED OPERATION RESULTING IN PROLONGED ANAESTHETIC TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782539 BD CONVENTIONAL NEEDLES SYRINGE, PISTON FMF BECTON DICKINSON, S.A. 00382903004003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention