BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 15420114 · Received September 14, 2022

    Report

    Report Number
    3003916417-2022-00189
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 19, 2022
    Report Date
    October 10, 2022
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1181262, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026, DEVICE MANUFACTURE DATE: 30-JUN-2021, MEDICAL DEVICE LOT #: 1030409, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026, DEVICE MANUFACTURE DATE: 30-JAN-2021.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 14SEP2022. H6: INVESTIGATION SUMMARY: TEN PACKAGED NEEDLE SAMPLES AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, NO DEFECTS OR ISSUES OBSERVED, CLOGGED NEEDLE COULD NOT BE CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ADDITIONALLY, RETENTION SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR DAMAGE OBSERVED, NO OBSTRUCTION FOUND ON THE NEEDLE LUMEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 540 BD ECLIPSE¿ NEEDLES WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN USING SOME NEEDLES FOR DRUGS ADMINISTRATION, THERE WAS RESISTANCE AND IT WAS OBSERVED THE NEEDLE LUMEN IS CLOSED, PREVENTING THE MEDICATION FLOW." "WAS THERE ANY DAMAGE/IMPACT TO PATIENT/HEALTH PROFESSIONAL? BECAUSE THE LUMEN OF THE NEEDLE WAS CLOSED, THE ADMINISTRATION COULD NOT BE DONE, BUT THERE WAS A NEED TO PIERCE THE PATIENTS AGAIN. WAS MEDICAL INTERVENTION NEEDED? NO, JUST THE DISCOMFORT OF HAVING TO PUNCTURE PATIENTS AGAIN. WHAT MEDICATION WAS BEING ADMINISTERED? DORMIRE 5MG/ML - AMPOLA DE 3 ML."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 149 BD ECLIPSE¿ NEEDLES WERE BLOCKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN USING SOME NEEDLES FOR DRUGS ADMINISTRATION, THERE WAS RESISTANCE AND IT WAS OBSERVED THE NEEDLE LUMEN IS CLOSED, PREVENTING THE MEDICATION FLOW." "- WAS THERE ANY DAMAGE/IMPACT TO PATIENT/HEALTH PROFESSIONAL? BECAUSE THE LUMEN OF THE NEEDLE WAS CLOSED, THE ADMINISTRATION COULD NOT BE DONE, BUT THERE WAS A NEED TO PIERCE THE PATIENTS AGAIN. - WAS MEDICAL INTERVENTION NEEDED? NO, JUST THE DISCOMFORT OF HAVING TO PUNCTURE PATIENTS AGAIN. - WHAT MEDICATION WAS BEING ADMINISTERED? DORMIRE 5MG/ML - AMPOLA DE 3 ML."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2496785 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown