BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 18021575 · Received October 27, 2023

    Report

    Report Number
    1024879-2023-00766
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    October 18, 2023
    Report Date
    November 29, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    30382903686095
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 368609 LOT/BATCH #: UNKNOWN BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SLEEVE FELL OFF CAUSING THE USER TO BE STUCK WITH THE USED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: THE DEPARTMENT STATES THAT DURING A BLOOD SAMPLE COLLECTION AT THE CONSULTATIONS, WHEN PRESSING THE PINK VALVE TO SECURE THE NEEDLE AFTER COLLECTION, THE PINK VALVE SECURING THE NEEDLE BECAME DETACHED FROM THE DM, AND THE EIDE PRICKED HIMSELF WITH THE HOLLOW NEEDLE, WHICH WAS NO LONGER PROTECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SLEEVE FELL OFF CAUSING THE USER TO BE STUCK WITH THE USED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: THE DEPARTMENT STATES THAT DURING A BLOOD SAMPLE COLLECTION AT THE CONSULTATIONS, WHEN PRESSING THE PINK VALVE TO SECURE THE NEEDLE AFTER COLLECTION, THE PINK VALVE SECURING THE NEEDLE BECAME DETACHED FROM THE DM, AND THE EIDE PRICKED HIMSELF WITH THE HOLLOW NEEDLE, WHICH WAS NO LONGER PROTECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911258 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) UNKNOWN 30382903686095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention