BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 18G 1 1/2IN

    MDR report key: 17391173 · Received July 25, 2023

    Report

    Report Number
    3003916417-2023-00171
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 3, 2023
    Report Date
    August 28, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 03-AUG-2023. H6: INVESTIGATION SUMMARY SAMPLE AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL EVALUATION, FOREIGN MATTER ON THE NEEDLE IS OBSERVED. FURTHER EVALUATION WAS PERFORMED, FOREIGN SUBSTANCE WAS MAINLY COMPOSED OF EPOXY, AN ADHESIVE USED TO JOIN THE CANNULA WITH THE HUB. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED FOR LOT 2180445, 2301995 ,3030005, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED PROBLEM WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE TEAMS INVESTIGATION, POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE VISION SYSTEM. VISION SYSTEMS ARE FREQUENTLY REVISED IN THE PREVENTIVE MAINTENANCE THAT TAKES PLACE EVERY FOUR MONTHS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2180445. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. H.4. DEVICE MANUFACTURE DATE: 29-JUN-2022. D.4. MEDICAL DEVICE LOT #: 2301995. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2027. H.4. DEVICE MANUFACTURE DATE: 28-OCT-2022. D.4. MEDICAL DEVICE LOT #: 3030005. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2027. H.4. DEVICE MANUFACTURE DATE: 30-JAN-2023. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD PRECISIONGLIDE NEEDLE 18G 1 1/2IN "WHITE DOTS" WERE DISCOVERED ON THE NEEDLE. THIS OCCURRED WITH 3 NEEDLES FROM LOT# 2180445 AND ONCE WITH LOT#S 2301995 AND 3030005. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: INFORMS THAT WHEN YOU TAKE THE NEEDLE OUT OF THE PACKAGE, YOU FIND SOME WHITE DOTS ON THE NEEDLE AND ON THE PACKAGE, AND YOU DON'T KNOW WHAT THEY ARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD PRECISIONGLIDE NEEDLE 18G 1 1/2IN "WHITE DOTS" WERE DISCOVERED ON THE NEEDLE. THIS OCCURRED WITH 3 NEEDLES FROM LOT# 2180445 AND ONCE WITH LOT#S 2301995 AND 3030005. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: INFORMS THAT WHEN YOU TAKE THE NEEDLE OUT OF THE PACKAGE, YOU FIND SOME WHITE DOTS ON THE NEEDLE AND ON THE PACKAGE, AND YOU DON'T KNOW WHAT THEY ARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809759 BD PRECISIONGLIDE NEEDLE 18G 1 1/2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown