BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 8574418 · Received May 2, 2019

    Report

    Report Number
    1024879-2019-00815
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER ADDITIONAL REVIEW, THIS REPORT IS A DUPLICATE REPORT OF MFR #1024879-2019-00819. THIS EVENT HAS BEEN OVER-REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY SHIELD FELL OFF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE AFTER COMPLETING THE BLOOD COLLECTION WHEN TRYING TO MOVE IT. LOT #'S 8298865, 9003943, AND 9038652 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STARTED USING ECLIPSE NEEDLE A MONTH AGO. THE SAFETY CAP "FALLS OFF" WHEN TRYING TO ACTIVATE AFTER BLOOD COLLECTION." "THE CUSTOMER USED TO USE THE SMITH STRAIGHT NEEDLE WHICH HAD A SAFETY DEVICE ATTACHED TO THE HOLDER. THE CUSTOMER IS USED TO MOVING AROUND THE SAFETY DEVICE WHICH COULD BE THE CAUSE WHY THE BD ECLIPSE IS FALLING OFF WHEN THEY TRY TO MOVE IT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8298865; MEDICAL DEVICE EXPIRATION DATE: 2023-10-31; DEVICE MANUFACTURE DATE: 2018-10-25; MEDICAL DEVICE LOT #: 9003943; MEDICAL DEVICE EXPIRATION DATE: 2023-12-31; DEVICE MANUFACTURE DATE: 2019-01-03; MEDICAL DEVICE LOT #: 9038652; MEDICAL DEVICE EXPIRATION DATE: 2024-01-31; DEVICE MANUFACTURE DATE: 2019-02-07. 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 SAFETY SHIELD FELL OFF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE AFTER COMPLETING THE BLOOD COLLECTION WHEN TRYING TO MOVE IT. LOT #'S 8298865, 9003943, AND 9038652 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STARTED USING ECLIPSE NEEDLE A MONTH AGO. THE SAFETY CAP "FALLS OFF" WHEN TRYING TO ACTIVATE AFTER BLOOD COLLECTION." "THE CUSTOMER USED TO USE THE SMITH STRAIGHT NEEDLE WHICH HAD A SAFETY DEVICE ATTACHED TO THE HOLDER. THE CUSTOMER IS USED TO MOVING AROUND THE SAFETY DEVICE WHICH COULD BE THE CAUSE WHY THE BD ECLIPSE IS FALLING OFF WHEN THEY TRY TO MOVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369468 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE SECTION H.10. 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other