BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 21 G X 1.25 IN.

    MDR report key: 7058696 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00379
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    June 2, 2016
    Report Date
    October 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    00382903686094
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). RESULTS: A PHOTOGRAPH WAS RETURNED FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE DEFECT WAS NOT CONFIRMED IN THE PHOTOGRAPH. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6041817. 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 THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 21 G X 1.25 IN. NEEDLE WAS NOT ATTACHED IN LINE WITH THE IV NEEDLE. THE SLEEVE COULD NOT RECOVER WHICH RESULTED IN A FAILURE TO CONTAIN BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841204 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 21 G X 1.25 IN. SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6041817 00382903686094

    Patients

    Seq Age Sex Outcome Treatment
    1 Other