BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 9262745 · Received October 31, 2019

    Report

    Report Number
    1024879-2019-01895
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686082
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 368608; BATCH NO: 9200798. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WHEN ATTACHING THE ECLIPSE SAFETY NEEDLE, THE SAFETY ARM BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ATTACHMENT OF ECLIPSE SAFETY NEEDLE ONTO TUBE HOLD THE PINK SAFETY MECHANISM BROKE OFF. "ECLIPSE SAFETY NEEDLE SAFETY ARM BROKE OFF."

    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.

    Description of Event or Problem · 1

    MATERIAL NO: 368608, BATCH NO: 9200798. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WHEN ATTACHING THE ECLIPSE SAFETY NEEDLE, THE SAFETY ARM BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ATTACHMENT OF ECLIPSE SAFETY NEEDLE ONTO TUBE HOLD THE PINK SAFETY MECHANISM BROKE OFF. "ECLIPSE SAFETY NEEDLE SAFETY ARM BROKE OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053393 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368608 9200789 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other