BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 22 G X 1.25 IN

    MDR report key: 7059632 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00672
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    December 17, 2015
    Report Date
    October 27, 2017
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: FOUR CUSTOMER SAMPLES WERE RECEIVED FOR EVALUATION. ONE SAMPLE WAS RECEIVED THREADED INTO A BD SINGLE USE HOLDER WITH THE SAFETY SHIELD ROD BROKEN OFF IN THE C COLLAR HOOK. TWO SINGLE SAMPLES WERE RECEIVED WITH THE SAFETY SHIELD RODS BROKEN OFF IN THE C COLLAR HOOK. ONE SAMPLE WAS RECEIVED WITH THE SAFETY SHIELD ENGAGED OVER THE IV CANNULA WITH NO SAFETY SHIELD ROD BREAKAGE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5200974. RESULTS: NO ASSIGNABLE ROOT CAUSE AND/OR CONTRIBUTING FACTORS THAT MAY LEAD THE SAFETY SHIELD BREAKING OFF WERE IDENTIFIED THROUGH THE INVESTIGATION PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PINK SAFETY DEVICE OF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 22 G X 1.25 IN IS BREAKING OFF WHEN ENGAGED AFTER COLLECTION. THERE ARE SOME INSTANCES WHERE THE PINK SHIELD WOULD BE BROKEN OFF IN THE BOX. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838770 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 22 G X 1.25 IN SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5200974 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other