BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20594307 · Received November 2, 2024

    Report

    Report Number
    3002682307-2024-00233
    Event Type
    Malfunction
    Date Received
    November 2, 2024
    Date of Event
    October 14, 2024
    Report Date
    February 25, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903006373
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE NEEDLE SAMPLE, THE CANNULA TIP WAS OBSERVED BROKEN. THE CANNULA IS WITHOUT THE CANNULA POINT GRIND. BASED ON THE PRODUCTION PROCESS, THE CANNULA POINT IS FORMED AT THE GRINDING PROCESS; HOWEVER, THE GRINDING PROCESS WOULD NOT RESULT IN A BROKEN CANNULA. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300637 AND LOT NUMBER 240722. 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. AN EXACT CAUSE FOR THE BROKEN CANNULA POINT COULD NOT BE DETERMINED AT THIS TIME. IN RESPONSE TO THIS INCIDENT, THE GRINDING AND FINAL INSPECTION ASSOCIATES HAVE BEEN ALERTED OF THIS INCIDENT TO RAISE FURTHER AWARENESS ON THE PRODUCTION FLOOR. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES, NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WE RECEIVED A COMPLAINT FROM A NURSING UNIT WITH US THAT THE TIP OF THE MICROLANCE NEEDLE 16G X 40MM WITH REFERENCE 300637 CRACKED OFF WHEN PULLING UP A PRODUCT. THE LOT OF THIS NEEDLE IS 240722. WE HAVE KEPT EVERYTHING FOR INVESTIGATION. 15 OCT 2024: NO IMPACT ON THE PATIENT. BROKE DOWN WHEN LIFTING A PRODUCT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175650 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240722 00382903006373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown