BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 18911668 · Received March 15, 2024

    Report

    Report Number
    3002682307-2024-00053
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 21, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903046447
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E. THE FULL ADDRESS PROVIDED DOES NOT FIT: (B)(6). H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304644 AND LOT NUMBER 2152363. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE AND SAMPLE WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. YELLOW RESIDUE WAS OBSERVED ON THE CANNULA OF THE NEEDLE PRODUCT. THE MATERIAL WAS IDENTIFIED AS A RESIDUE PRODUCED DURING THE EPOXY CURING PROCESS. IT IS THE CONDENSED VAPOR OF THE EPOXY ADHESIVE, WHICH DROPPED ONTO THE CANNULAS SURFACE. THIS DEFECT RESULTED DURING THE ASSEMBLY PROCESS, WHEN THE PRODUCT ENTERS THE OVEN FOR CURING. THE OVEN IS ROUTINELY CLEANED AND ALL RECORDS OF CLEANING WERE FOUND TO BE IN COMPLIANCE. HOWEVER, THE MANUFACTURING PERSONNEL HAVE BEEN ALERTED OF THIS INCIDENT TO RAISE FURTHER AWARENESS ON THE PRODUCTION FLOOR. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. 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 NOTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: I'M ENCLOSING A REPORT OF A DEFECT FOUND WHEN USING 18G PINK CANULAS IN PRODUCTION. - PRESENCE OF YELLOWISH PARTICLES INSIDE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471135 BD CONVENTIONAL NEEDLES NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 2152363 00382903046447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown