BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 22GA 1-1/2IN

    MDR report key: 19536275 · Received June 14, 2024

    Report

    Report Number
    3002682307-2024-00135
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903010004
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 301000 AND LOT NUMBER 220922. 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, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURES SHOWED A NEEDLE WITH A TWISTED HUB AND A NEEDLE WHICH PRESENTED NO DEFECT. ALTHOUGH THE REPORTED DEFECT COULD BE CONFIRMED, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED AS IT IS INTERPRETED THAT THE NEEDLE WAS NOT TWISTED BEFORE USE. WE CANNOT EXCLUDE THAT THE HANDLING OF THE PRODUCT OR ANY INCOMPATIBILITIES BETWEEN THE DEVICES USED HAD A POTENTIAL IMPACT IN THIS 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

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 22GA 1-1/2IN NEEDLE HUB WAS TWISTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ONE OF THE STEPS IN THE MANUFACTURING PROCESS, A LEAK WAS DISCOVERED, AND IT TURNED OUT TO BE THE FAULTY MICROLANCE WHICH IS TWISTED. VENDOR BATCH #: 220922. THE PHOTO WITH TWO MICROLANCES, THE TOP ONE IS DEFECTIVE. THE BOTTOM ONE IS TO SHOW WHAT IT SHOULD LOOK LIKE. THE GRAY AREA IS TWISTED. I AM ALSO ATTACHING THE PHOTO FOR YOUR REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393856 BD NEEDLE 22GA 1-1/2IN NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 220922 00382903010004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown