BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 10417973 · Received August 17, 2020

    Report

    Report Number
    3002682307-2020-00251
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    October 15, 2019
    Report Date
    September 23, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1904003 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND FUNCTIONALLY TESTED; NO DEFECTS WERE IDENTIFIED. COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE DREW UP THE MEDICATION DURING USE, BUT WOULD NOT INJECT IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "ACCORDING TO SEVERAL NURSES, THE NEEDLES WERE USED TO WITHDRAW BUT NOT TO RE-INJECT THE PRODUCT. MALFUNCTIONS ON THE SAME BATCH."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE DREW UP THE MEDICATION DURING USE, BUT WOULD NOT INJECT IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "ACCORDING TO SEVERAL NURSES, THE NEEDLES WERE USED TO WITHDRAW BUT NOT TO REINJECT THE PRODUCT. MALFUNCTIONS ON THE SAME BATCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876480 BD ECLIPSE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1904003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other