BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GX1/2 IN

    MDR report key: 12291696 · Received August 6, 2021

    Report

    Report Number
    3002682307-2021-00392
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 30, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 191020, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: 2019-10-29. MEDICAL DEVICE LOT #: 180413, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2018-04-04. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 191020. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 180413. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, A THOROUGH ANALYSIS COULD NOT BE COMPLETED FOR THE AFFECTED PRODUCT. TO FURTHER EVALUATE THIS INCIDENT, TWENTY RETAINED SAMPLES (TEN FOR EACH LOT NUMBER PROVIDED) WERE OBTAINED FROM THE MANUFACTURING FACILITY BY OUR QUALITY ENGINEER TEAM. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS WERE IDENTIFIED. REGRETTABLY, PER THE PROVIDED FEEDBACK, A DEFINITIVE CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. INVESTIGATION CONCLUSION: REGRETTABLY, WITH THE INFORMATION PROVIDED ¿THE HOSPITAL STAFF FOUND WATER BEADS IN THE NEEDLES AFTER OPENING THE FOLDING BOXES¿ DEFECT CANNOT BE CONFIRMED NEITHER A ROOT CAUSE FINDING RELATED WITH THE MANUFACTURING OF THE PRODUCT CAN BE STABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 NEEDLE 30GX1/2 IN EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STAFF BELIEVED THAT THE NEEDLES OF 2 PRODUCTS OF LUCENTIS WERE CONTAMINATED (THE HOSPITAL STAFF FOUND WATER BEADS IN THE NEEDLES AFTER OPENING THE FOLDING BOXES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188394 NEEDLE 30GX1/2 IN NEEDLE FMI BECTON DICKINSON, S.A. 180413

    Patients

    Seq Age Sex Outcome Treatment
    1