BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE 18 G

    MDR report key: 17401272 · Received July 26, 2023

    Report

    Report Number
    3003916417-2023-00174
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    June 20, 2023
    Report Date
    August 4, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 27-JUL-2023. H.6. INVESTIGATION SUMMARY: SAMPLES AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL EVALUATION OF IMAGES, SYRINGE AND NEEDLE ATTACHED TO THE VIAL IS OBSERVED, NO CORING OBSERVED. PHYSICAL SAMPLES RECEIVED SHOWED NO DEFECTS OR ISSUES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2243477, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. RETENTION SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ BLUNT FILL NEEDLE 18 G FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: PRESENCE OF A RUBBER FRAGMENT WHEN PUNCTURING THE VIAL. MATERIAL IS TRAPPED INSIDE THE NEEDLE OR VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ BLUNT FILL NEEDLE 18 G FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: PRESENCE OF A RUBBER FRAGMENT WHEN PUNCTURING THE VIAL. MATERIAL IS TRAPPED INSIDE THE NEEDLE OR VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645261 BD¿ BLUNT FILL NEEDLE 18 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 2243477

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown