BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 21 G X 1.5 IN. MULTI SAMPLE BLOOD COLLECTION NEEDLE

    MDR report key: 7072903 · Received November 30, 2017

    Report

    Report Number
    9617032-2017-00271
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    December 10, 2015
    Report Date
    November 1, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A PHOTO WAS RECEIVED SHOWING THE REPORTED FOREIGN MATTER ON THE IV CANNULA. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 4093021. 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 FOREIGN MATTER WAS FOUND ON A BD VACUTAINER® 21 G X 1.5 IN. MULTI SAMPLE BLOOD COLLECTION NEEDLE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852322 BD VACUTAINER® 21 G X 1.5 IN. MULTI SAMPLE BLOOD COLLECTION NEEDLE SAMPLE NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 4093021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other