BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 9354809 · Received November 21, 2019

    Report

    Report Number
    3002682307-2019-00613
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K100209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 305895, LOT 1903010 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. AFTER REVIEWING OUR PRODUCTION AND INSPECTION RECORDS, IT IS NOT POSSIBLE TO PERFORM AN ACCURATE INVESTIGATION OF THE REPORTED ISSUE AND DETERMINE THAT THE REPORTED FAILURE MODE IS RELATED WITH NEEDLE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT THE TIME OF INJECTION THE SAFETY MECHANISM DISENGAGED WITH A BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE SAFETY SYSTEM OF THE NEEDLE GOT DISENGAGED AT THE TIME OF INJECTION. NO CONSEQUENCES WERE FOUND. I'M WAITING TO KNOW IF THE SERVICE HAS KEPT THE NEEDLE CONCERNED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AT THE TIME OF INJECTION THE SAFETY MECHANISM DISENGAGED WITH A BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE SAFETY SYSTEM OF THE NEEDLE GOT DISENGAGED AT THE TIME OF INJECTION. NO CONSEQUENCES WERE FOUND. I'M WAITING TO KNOW IF THE SERVICE HAS KEPT THE NEEDLE CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153966 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1903010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other