BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 9593612 · Received January 15, 2020

    Report

    Report Number
    1024879-2020-00006
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 31, 2019
    Report Date
    March 31, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE SAMPLES WERE EVALUATED AND DEFECTIVE LOCKING MECHANISM WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION IN ORDER TO IDENTIFY EMERGING TRENDS. BASED ON THE INVESTIGATION, THE MOST LIKELY CAUSE IS PLASTIC FLASH WHICH CREATED A TIGHT FITMENT BETWEEN THE PIVOT SHIELD AND COLLAR; THUS, RESTRICTING THE MOVEMENT OF THE PIVOT SHIELD FORCING IT TO BREAK OFF. IN REVIEW OF HISTORICAL PIR DATA THIS APPEARS TO BE AN ISOLATED INCIDENT AND NOT REPRESENTATIVE OF THE OVERALL BATCH QUALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY SHIELD ON THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE BROKE IN TWO PIECES DURING USE WHEN ATTEMPTING TO ACTIVATE IT AFTER DRAWING LABS ON A PATIENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR LAB TECHNICIAN DREW LABS ON A PATIENT THIS MORNING. WHEN HE WENT TO ACTIVATE THE SAFETY DEVICE, THE SAFETY DEVICE FELL APART, AND WAS NO LONGER ABLE TO BE ACTIVATED. IT BROKE INTO 2 PIECES AND COMPLETELY SEPARATED FROM THE NEEDLE." PRODUCT WAS ECLIPSE VENIPUNCTURE NEEDLE 22G 1 ¼¿. LOT 9241845, EXP 8/31/2024, DATE OF INCIDENT WAS (B)(6) 2019. THERE WAS NO EXPOSURE, BUT IT COULD HAVE EASILY LEAD TO AN EXPOSURE. NO ERRONEOUS RESULTS REPORTED- INCIDENT OCCURRED AFTER THE BLOOD DRAW WHEN THE SAFETY MECHANISM WAS BEING ENGAGED. THE SAFETY MECHANISM BROKE INTO TWO PIECES.

    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

    IT WAS REPORTED THAT THE SAFETY SHIELD ON THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE BROKE IN TWO PIECES DURING USE WHEN ATTEMPTING TO ACTIVATE IT AFTER DRAWING LABS ON A PATIENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR LAB TECHNICIAN DREW LABS ON A PATIENT THIS MORNING. WHEN HE WENT TO ACTIVATE THE SAFETY DEVICE, THE SAFETY DEVICE FELL APART, AND WAS NO LONGER ABLE TO BE ACTIVATED. IT BROKE INTO 2 PIECES AND COMPLETELY SEPARATED FROM THE NEEDLE." PRODUCT WAS ECLIPSE VENIPUNCTURE NEEDLE 22G 1 ¼¿. LOT 9241845, EXP 8/31/2024, DATE OF INCIDENT WAS (B)(6) 2019. THERE WAS NO EXPOSURE, BUT IT COULD HAVE EASILY LEAD TO AN EXPOSURE. NO ERRONEOUS RESULTS REPORTED- INCIDENT OCCURRED AFTER THE BLOOD DRAW WHEN THE SAFETY MECHANISM WAS BEING ENGAGED. THE SAFETY MECHANISM BROKE INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57228 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368608 9241845 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other