BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA BLUNT PLASTIC

    MDR report key: 20833378 · Received December 3, 2024

    Report

    Report Number
    1911916-2024-00867
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 10, 2024
    Report Date
    January 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903033454
    PMA / PMN Number
    K974363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THE PLASTIC CANNULA THAT BROKE WHILE TRYING TO DRAW MEDICATION. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE CANNULA TIP IS BENT. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303345, LOT 4060239. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. 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 RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 303345 BATCH NUMBER#: 4060239 VERBATIM#: WE HAD A BD BLUNT PLASTIC CANNULA THAT BROKE WHILE TRYING TO DRAW MEDICATION, THE REF NUMBER IS 303345 LOT 4060239. THIS HAS BEEN THE ONLY OCCURRENCE THAT I AM AWARE OF, I HAVE THE NEEDLE IF YOU WANT TO EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210001 CANNULA BLUNT PLASTIC NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4060239 00382903033454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown