BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 6419599 · Received March 20, 2017

    Report

    Report Number
    1024879-2017-00025
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 24, 2017
    Report Date
    April 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6161679. CONCLUSION: WITHOUT A SAMPLE, 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 SAFETY SHIELD FELL OFF THE SUSPECT DEVICE WHEN THE CLINICIAN WAS ATTEMPTING TO CLOSE THE SHIELD OVER THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199189 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6161679

    Patients

    Seq Age Sex Outcome Treatment
    1 Other