BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ SAFETY NEEDLE - 23G

    MDR report key: 15928754 · Received December 6, 2022

    Report

    Report Number
    3002682307-2022-00332
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    October 31, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 09-DEC-2022. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305892 AND LOT NUMBER 1812001. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PACKAGED NEEDLES AND ONE (1) UNPACKAGE NEEDLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. IN ONE OF THE PACKAGED NEEDLES, NO DEFECT WAS OBSERVED. HOWEVER, IN THE OTHER SAMPLES RECEIVED, SMALL BLACK SPOTS IN THE HUB COMPONENT WERE OBSERVED. AFTER EXAMINATION, WE WERE ABLE TO IDENTIFY THE SPOTS AS EMBEDDED CONTAMINATION (A COSMETIC DEFECT). EMBEDDED CONTAMINATION MAY OCCUR DURING THE MOLDING PROCESS DUE TO THE HIGH WORKING TEMPERATURES. DURING NORMAL PRODUCTION, THE GASES PRODUCED IN THE MOLDS ARE EXPELLED THROUGH SOME CONDUITS. IN THIS CASE, THE EXPULSION WAS NOT CORRECTLY DONE, CAUSING SOME GASES TO REMAIN AND PRODUCE BURNT PARTICLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ECLIPSE¿ SAFETY NEEDLE - 23G FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK SPOTS DETECTED IN SEALED PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ECLIPSE¿ SAFETY NEEDLE - 23G FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK SPOTS DETECTED IN SEALED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2541204 BD ECLIPSE¿ SAFETY NEEDLE - 23G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1812001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown