BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE WITH SLIP-TIP HUB CONFIGURATION

    MDR report key: 16591725 · Received March 22, 2023

    Report

    Report Number
    3002682307-2023-00076
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305895 AND THE ONE KNOWN LOT NUMBER 2202015. 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, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FOR EVALUATION FROM THE MANUFACTURING FACILITY; HOWEVER, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF DEFECT. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT.

    Additional Manufacturer Narrative · 0

    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: MEDICAL DEVICE LOT #: 2202015. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 18-FEB-2022. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 1 BD ECLIPSE¿ NEEDLE WITH SLIP-TIP HUB CONFIGURATION FROM LOT 2202015, AND 2 NEEDLES FROM AN UNSPECIFIED LOT WERE FOUND WITH FOREIGN MATTER ON THEM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING A KNEE JOINT INJECTION, I NOTICED A WHITE FOREIGN BODY ON THE NEEDLE I WAS USING (21G), I IMMEDIATELY WITHDREW THE NEEDLE, CHANGED IT FOR A FRESH ONE AND CONTINUED WITH THE PROCEDURE. LATER IN MY CLINIC I NOTICED A FURTHER ARTIFACT ON ANOTHER 21G NEEDLE I WAS USING TO DRAW UP MEDICATION. ON CHECKING MY SUPPLY OF 21G NEEDLES I FOUND THIRD NEEDLE WITH A GREEN ARTIFACT ON IT".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ECLIPSE¿ NEEDLE WITH SLIP-TIP HUB CONFIGURATION FROM LOT 2202015, AND 2 NEEDLES FROM AN UNSPECIFIED LOT WERE FOUND WITH FOREIGN MATTER ON THEM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING A KNEE JOINT INJECTION, I NOTICED A WHITE FOREIGN BODY ON THE NEEDLE I WAS USING (21G), I IMMEDIATELY WITHDREW THE NEEDLE, CHANGED IT FOR A FRESH ONE AND CONTINUED WITH THE PROCEDURE. LATER IN MY CLINIC I NOTICED A FURTHER ARTIFACT ON ANOTHER 21G NEEDLE I WAS USING TO DRAW UP MEDICATION. ON CHECKING MY SUPPLY OF 21G NEEDLES I FOUND THIRD NEEDLE WITH A GREEN ARTIFACT ON IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436271 BD ECLIPSE¿ NEEDLE WITH SLIP-TIP HUB CONFIGURATION HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown