BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE NEEDLES

    MDR report key: 21899851 · Received April 24, 2025

    Report

    Report Number
    3002682307-2025-00051
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    December 18, 2024
    Report Date
    May 29, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 240202. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED 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, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, A HUB WITH SOME SMALL BLACK PARTICLE WAS OBSERVED. HOWEVER, WITHOUT THE PHYSICAL SAMPLE IT WAS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE FOREIGN MATTER DETECTED. TWENTY (20) ADDITIONAL RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED. BD KEEPS THE FOREIGN MATTER TO EXTREMELY LOW LEVELS DUE TO THE STRINGENT PREVENTIVE MEASURES IN PLACE. THE ENTIRE ASSEMBLY AND PACKAGING PROCESS TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE GOOD MANUFACTURING PRACTICES ARE FOLLOWED. THIS IS THE FIRST TIME THIS LOT NUMBER HAS RECEIVED A COMPLAINT FOR THIS DEFECT AND NO OTHER COMPLAINTS FROM OTHER CUSTOMERS HAVE BEEN RECEIVED. NO CHANGES IN THE PRODUCTION PROCESS THAT COULD HAVE BEEN RELATED TO THIS REPORTED ISSUE HAVE BEEN PERFORMED EITHER. WE ARE CONFIDENT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES FOREIGN MATTER IN HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: OUR CUSTOMER HAS DISCOVERED A BLACK PARTICLE IN THE HUB OF ONE OF YOUR CANNULAS. IT IS THE REF 304000 ¿BD® MICROLANCE¿ 3 NEEDLE 30G X ½¿ (0.3 × 13 MM)¿ WITH THE LOT 240202. I AM PLEASED TO SEND YOU THE CUSTOMER'S PHOTOS IN THE ATTACHMENT. IN ORDER TO RULE OUT POSSIBLE QUALITY OR PRODUCTION PROBLEMS, WE WOULD LIKE TO ASK YOU TO CHECK THE CAUSE OF THE OCCURRENCE OF THIS PARTICLE AND LET US KNOW WHERE IT MAY HAVE COME FROM. HAS THERE ALREADY BEEN SIMILAR FEEDBACK FROM OTHER CUSTOMERS? COULD YOU PLEASE PROVIDE A DATE OF EVENT WHEN THE ISSUE WAS NOTICED? 18.12.2024. COULD YOU PLEASE CONFIRM WHEN THIS ISSUE HAPPENED IE BEFORE USE OR DURING OR AFTER USE AND IS THERE ANY HARM REPORTED CUSTOMER? THE BLACK SPOT WAS DETECTED BEFORE USING THE CANNULA. AFTER SPOTTING, THE CANNULA WAS NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289183 BD MICROLANCE NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240202 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown