BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP

    MDR report key: 12312076 · Received August 12, 2021

    Report

    Report Number
    3002682307-2021-00406
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    May 20, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    50382903058919
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2012009. 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, PICTURES OF THE AFFECTED SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. HOWEVER, THROUGH EXAMINATION OF THE PICTURES, NO QUALITY DEFECTS COULD BE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BENT UNABLE TO USE AFTER GOING THROUGH THE RUBBER STOPPER OF A VACCINE VIAL. THE SECOND NEEDLE LEAKS AT THE HUB OF THE NEEDLE. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BENT UNABLE TO USE AFTER GOING THROUGH THE RUBBER STOPPER OF A VACCINE VIAL. THE SECOND NEEDLE LEAKS AT THE HUB OF THE NEEDLE. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208645 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 305891 2012009 50382903058919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown