BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 21021674 · Received December 26, 2024

    Report

    Report Number
    3002682307-2024-00258
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    August 23, 2024
    Report Date
    January 22, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903044320
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND LOT NUMBER 230701. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE OF THE NEEDLE PRODUCT¿S SHELF CARTON LABEL WAS PROVIDED AND PHYSICAL SYRINGE SAMPLES WERE RETURNED (INVESTIGATED UNDER (B)(4)). THROUGH EVALUATION OF THE SAMPLES, A DEFECT RELATED TO THE NEEDLE PRODUCT COULD NOT BE IDENTIFIED. REGRETTABLY, WITH THE INFORMATION PROVIDED, WE WERE UNABLE TO DETERMINE A CAUSE RELATED TO THE MANUFACTURING PROCESS FOR THIS INCIDENT. IF ALL AFFECTED MATERIALS BECOME AVAILABLE, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. PER THE PROVIDED FEEDBACK OF ¿THE PARTICULATE IS WHITE AND THUS MOST CLOSELY ALIGNS WITH THE ADHESIVE¿. WE WOULD LIKE TO INFORM YOU THAT DURING THE ASSEMBLY PROCESS, THE EPOXY (ADHESIVE USED TO JOIN THE CANNULA AND HUB COMPONENTS) IS CURED IN AN OVEN. AFTER THIS CURING PROCESS, IT IS PRACTICALLY IMPOSSIBLE FOR THE EPOXY TO GENERATE ANY FOREIGN PARTICLES THAT WOULD END UP IN THE FLUID PATHWAY. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CLINICAL SITE FOUND WHITE PARTICLES FLOATING IN THE DRUG PRODUCT AFTER WITHDRAWING THE DRUG PRODUCT FROM A VIAL WITH BD LUER LOCK SYRINGE AND MICROLANCE 3 NEEDLE. THERE WERE 6 OBSERVATIONS OF PARTICLES IN SYRINGES. THIS PARTICULATE IS NOT DRUG OR CONTAINER (VIAL + STOPPER) RELATED. IT MAY BE PART FOR THE NEEDLE/SYRINGE SYSTEM USED FOR DRUG EXTRACTION FROM THE VIAL. THE PARTICULATE IS WHITE AND THUS MOST CLOSELY ALIGNS WITH THE ADHESIVE USED BY BD TO BOND THE NEEDLE TO THE NEEDLE HUB OF THE BD MICROLANCE NEEDLE. 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE. PARTICLES IN SYRINGE DETECTED BEFORE ADMINISTRATION TO PATIENT. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 23-AUG-2024, 30-AUG-2024, 05-SEP-2024. 3. TOTAL NUMBER OF OCCURRENCES ONLY MATERIAL#: 304432? SIX SYRINGES CONTAINED WHITE PARTICLES. NOT ABLE TO DETERMINE WHICH NEEDLE WAS USED WITH EACH SYRINGE. 4. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SIX SYRINGES WITHOUT THE NEEDLES ARE AVAILABLE. ONE REPRESENTATIVE PHOTO IS ATTACHED. CAN BD ACCEPT SYRINGES FILLED WITH BIOLOGIC DRUG PRODUCT? PLEASE SEND RETURN LABEL TO (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429838 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 230701 00382903044320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown