BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 21767688 · Received April 3, 2025

    Report

    Report Number
    3002682307-2025-00044
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 19, 2025
    Report Date
    May 12, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 231109. 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, TWENTY (20) NEEDLE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, TWO (2) NEEDLES HAD THE BLISTER PACKAGING ALREADY OPENED AND THE PACKAGING PAPER WAS BROKEN. THE REMAINING EIGHTEEN (18) NEEDLES WERE NOT OPENED. THE BLISTER PACKAGES WERE OPENED BY THE INVESTIGATIVE TEAM WITHOUT ANY ISSUE AND NONE OF THE PACKAGING PAPER HAD DAMAGE. REGARDING THE BLISTER PACKAGING ISSUE, THE FILM AND PAPER OF THE UNIT PACKAGE ARE SEALED BY PRESSURE AND TEMPERATURE. BOTH PARAMETERS ARE AUTOMATICALLY CONTROLLED AND VERIFIED BY THE OPERATORS. ADDITIONALLY, SEALING DEFECT IN THE PRODUCT IS EVALUATED AS A PART OF THE IN-PROCESS INSPECTIONS. CONSIDERING THAT THE UNUSED SAMPLES PROVIDED NO DEFECTS, WE CANNOT DISCARD THE POSSIBILITY THAT HANDLING HAD AN IMPACT ON THE REPORTED ISSUE. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES, STERILITY IS COMPROMISED DURING OPENING OF PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: WHEN DID THE INCIDENT OCCUR? DURING USE. THE CANNULAS ARE VERY DIFFICULT TO OPEN STERILELY. OFTEN, THE PAPER IS DIFFICULT TO SEPARATE FROM THE FOIL, AND THE REMAINING PAPER RESIDUE CAUSES THE CANNULA TO BECOME UNSTERILE. THIS HAPPENS AT LEAST 3 TIMES OUT OF 10 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460019 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 231109 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown