BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 10551638 · Received September 17, 2020

    Report

    Report Number
    8041187-2020-00587
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057895
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE WITH A BD ECLIPSE¿ NEEDLE THE SAFETY MECHANISM DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 5 COMPLAINTS) IT WAS REPORTED THAT THE SHIELD FELL OFF. - THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES AND 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMF, COMMON DEVICE NAME: PISTON SYRINGE, PMA / 510(K)#: K941562. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED. (B)(6) WAS USED AS A PLACE HOLDER BASED ON THE USER AREA CODE AND INITIAL REPORTER FACILITY. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE WITH A BD ECLIPSE¿ NEEDLE THE SAFETY MECHANISM DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 5 COMPLAINTS). IT WAS REPORTED THAT THE SHIELD FELL OFF. THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016124 BD ECLIPSE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305789 UNKNOWN 30382903057895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other