BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CONVENTIONAL NEEDLE

    MDR report key: 18899507 · Received March 13, 2024

    Report

    Report Number
    3002682307-2024-00052
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    February 9, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903006007
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E/F CODES UPDATE. SI CAPTURE. UPON FURTHER REVIEW OF THE COMPLAINT RECORD, IT WAS IDENTIFIED THAT THE CUSTOMER INDICATED THAT THE NEEDLE REMAINED IN THE PATIENT WAS NOT CAPTURED IN THE INITIAL MDR. NO RESPONSE TO QUERIES FOR FURTHER INFORMATION REGARDING IMPACT AND OUTCOME.

    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

    IT WAS REPORTED THE MICROLANCE NEEDLE BROKE AND REMAINED IN THE PATIENT. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PICTURE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURE SHOWS THREE PACKED AND UNUSED NEEDLES. NO DEFECTS CAN BE OBSERVED, AND THE DEFECT IS NOT CONFIRMED. BREAKAGE OF THE NEEDLE IS RARE UNLESS THERE IS SOME INAPPROPRIATE USE OF THE PRODUCT, SUCH AS BENDING OF THE NEEDLE DURING INJECTION. PRODUCTION AND INSPECTION RECORDS WERE REVIEWED FOR PROVIDED MATERIAL NUMBER 300600, LOT 230904. ALL PRODUCTION AND PROCESSES WERE CARRIED OUT NORMALLY. NO PROBLEMS, DEFECTS OR RELATED QUALITY NOTIFICATIONS WERE FOUND TO THE REPORTED ISSUE. DAILY COMMENTS FROM THE SHIFT LEADER REGARDING ANY ISSUE IN THE ASSEMBLY MACHINES WERE ALSO REVIEWED FROM THE DATES WHEN THIS LOT WAS MANUFACTURED. THERE WAS NO OBSERVATION OF ANY ACTIVITY WHICH COULD POTENTIALLY BE RELATED WITH THE REPORTED ISSUE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 0

    MICROLANCE NEEDLE BREAKAGE THAT REMAINED INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLE, NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE SPOKEN WITH THE SUPERVISOR, (B)(6) . ALSO WITH THE DR. WHO WAS IN CHARGE OF THE PUNCTURE TECHNIQUE. THEY TOLD ME THAT THE INCIDENT OCCURRED WHEN THEY WERE DOING AN INFILTRATION WITH 1% LIDOCAINE, PRIOR TO AN EPIDURAL PUNCTURE. ACCORDING TO WHAT I WAS TOLD, THE NEEDLE WAS BROKEN AT THE LEVEL OF THE EPOXY RESIN THAT FIXES THE STEEL CANNULA TO THE SYRINGE CONNECTION PAVILION, SINCE HE COULD SEE THE STEEL EMBEDDED IN THE RESIN. I HAVE ASKED FOR PHOTOGRAPHS OR THE AFFECTED PAVILION ITSELF, BUT IT HAD BEEN DISCARDED, SO WE CANNOT ATTACH GRAPHIC DOCUMENT. I HAVE ALSO CONTACTED (B)(6) (RRMM) BEFORE AND AFTER SPEAKING WITH THE SERVICE, TO KEEP HER INFORMED OF THE PROCESS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450099 BD CONVENTIONAL NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 230904 00382903006007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other