BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 16018197 · Received December 20, 2022

    Report

    Report Number
    3002682307-2022-00347
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 24, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305892 AND LOT NUMBER 2102013. 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 RETAINED SAMPLES OF THE PROVIDED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION. NO DEFECTS WERE OBSERVED WITH THE SAFETY MECHANISMS OF THE RETAINED SAMPLES. IT WAS POSSIBLE TO CORRECTLY ACTIVATE THE SAFETY MECHANISMS BY FOLLOWING THE PRODUCT¿S INSTRUCTIONS FOR USE. TWENTY RETAINED SAMPLES WERE ALSO ASSEMBLED WITH A BD DISCARDIT 2ML SYRINGE. NO SIGNS OF DEFECTIVE HUB CONNECTION THAT COULD RESULT IN LEAKAGE WERE OBSERVED IN ANY OF THE RETAINED SAMPLES. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE NEEDLE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. PRIOR TO PRODUCT RELEASE, EACH LOT NUMBER IS TESTED FOR A FINAL SAFETY SHIELD ACTIVATION TEST. LOT NUMBER 2102013 WAS FOUND TO COMPLY WITH ALL SPECIFICATIONS. THE ASSEMBLY PROCESS HAS A SYSTEM WHICH INSPECTS ALL PRODUCT FOR PROPER OPENING AND ACTIVATING OF SAFETY SHIELDS AND AUTOMATICALLY REJECTS ANY DEFECTS IDENTIFIED. THE FINAL RELEASE TEST RESULTS FOR ENGAGEMENT FORCE WERE ALSO FOUND TO BE WITHIN SPECIFICATION FOR THIS LOT. SMARTSLIP TECHNOLOGY ¿ HAS BEEN INTRODUCED TO ENSURE A SECURE CONNECTION IS MADE WITH THE NEEDLE AND LUER SLIP SYRINGES.

    Additional Manufacturer Narrative · 0

    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 THE BD ECLIPSE¿ NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:IN CONNECTION WITH VACCINATION LEAKAGE A FEW DROPS BETWEEN THE NEEDLE AND THE SYRINGE AND THAT THE SAFETY COVER LOCK DETACHED FROM THE MOUNT. RISK OF STAB INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN CONNECTION WITH VACCINATION LEAKAGE A FEW DROPS BETWEEN THE NEEDLE AND THE SYRINGE AND THAT THE SAFETY COVER LOCK DETACHED FROM THE MOUNT. RISK OF STAB INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747374 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 2102013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown