BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 11230166 · Received January 26, 2021

    Report

    Report Number
    1024879-2021-00046
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    December 23, 2020
    Report Date
    February 23, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-02-03. H6: INVESTIGATION SUMMARY: BD RECEIVED 48 BD ECLIPSE NEEDLES FROM 2 DIFFERENT LOTS 0022977 AND 9309548 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL ACTIVATION TESTING AND THE INDICATED FAILURE MODE FOR DIFFICULT TO ACTIVATE WITH THE INCIDENT LOT WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES RESULTED IN A POST USE NEEDLE INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CAP OF GREEN SAFETY NEEDLES NOT ALIGNED RESULTING IN 2 NEEDLE STICK INJURIES-DURING USE BATCH OF GREEN SAFETY NEEDLES REMOVED FROM CIRCULATION IN THE PHLEBOTOMY TEAM IN (B)(6) HOSPITAL DUE TO THE CAP BEING OUT OF ALIGNMENT AND NOT CLOSING OVER THE NEEDLE AFTER USE, TWO STAFF HAVE HAD NEEDLE STICK INJURIES."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES RESULTED IN A POST USE NEEDLE INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CAP OF GREEN SAFETY NEEDLES NOT ALIGNED RESULTING IN 2 NEEDLE STICK INJURIES-DURING USE BATCH OF GREEN SAFETY NEEDLES REMOVED FROM CIRCULATION IN THE PHLEBOTOMY TEAM IN (B)(6) HOSPITAL DUE TO THE CAP BEING OUT OF ALIGNMENT AND NOT CLOSING OVER THE NEEDLE AFTER USE, TWO STAFF HAVE HAD NEEDLE STICK INJURIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128820 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE PISTON SYRINGE FMF BECTON, DICKINSON & CO., (BD) 9309548

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention