BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 22X1 RB

    MDR report key: 19762464 · Received July 17, 2024

    Report

    Report Number
    1911916-2024-00512
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051558
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305155 AND LOT NUMBER 1300351. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    MATERIALS#: 305155. BATCH#: 1300351. IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER WHO DOES WEEKLY INJECTION NOTICED THAT THERE WAS 3 OF ITEM 305196 LOT 1120197 AND 2 OF ITEM 305196 LOT -2327243 WITHIN THE BOX OF 100 COUNT ITEM 305155.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361811 NEEDLE 22X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 1300351 30382903051558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown