BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20351878 · Received October 2, 2024

    Report

    Report Number
    3002682307-2024-00202
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 6, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBERS 240514 AND 210910. 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, ONE (1) PICTURE AND NINE (9) SHELF CARTONS OF ONE HUNDRED (100) NEEDLES EACH WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PACKAGING STRIPS PROVIDED, THE TOP WEB COMPONENTS WERE OBSERVED SLIGHTLY YELLOWED. ADDITIONAL RETAINED SAMPLES WERE ALSO OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW; HOWEVER, THE RETAINED SAMPLES DID NOT SHOW THE AFFECTED TOP WEB. IT HAS BEEN DETERMINED THAT THE YELLOWED PACKAGING MATERIAL MAY HAVE RESULTED FROM A DEFECT IN THE PAPER REEL. WE BELIEVE THAT THIS WAS A TEMPORARY ISSUE IN THE PAPER REEL AND THE WHOLE REEL WAS NOT AFFECTED. ONE (1) PAPER REEL CONSISTS OF 1,600 METERS AND FOR THE MANUFACTURE OF THE 900 AFFECTED NEEDLES RETURNED, ONLY ABOUT 4 METERS OF THE PAPER REEL IS NEEDED. A NOTIFICATION REGARDING THIS INCIDENT HAS BEEN SENT TO THE PAPER REEL SUPPLIER. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. 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.

    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

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES PRIMARY PACKAGE IS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: WE HAVE ENCOUNTERED YELLOWING ON THE BACK OF THE PRIMARY PACKAGING PAPER AS CAN BE SEEN IN THE ATTACHED PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007345 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 210910 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown