BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 7066534 · Received November 29, 2017

    Report

    Report Number
    1024879-2017-00236
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    November 25, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOTS WERE ADDRESSED MEDICAL DEVICE LOT # 5211935, MEDICAL DEVICE EXPIRATION DATE: 07/31/2020, DEVICE MANUFACTURE DATE: 07/30/2015. MEDICAL DEVICE LOT # 5252621, MEDICAL DEVICE EXPIRATION DATE: 08/31/2020, DEVICE MANUFACTURE DATE: 09/09/2015. RESULTS: 48 SAMPLES WERE RECEIVED AND EVALUATED FOR DEFECTIVE LOCKING OF THE SAFETY WITH NO DEFECTS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 22 G X 1.25 IN SAFETY CAP WAS FALLING OFF OR NOT LOCKING INTO PLACE. NO INJURY, NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845971 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5282696 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other