BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7077390 · Received December 1, 2017

    Report

    Report Number
    1917413-2017-00394
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    February 27, 2016
    Report Date
    November 7, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JTW
    PMA / PMN Number
    K790366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED TO BD FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5182571. 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 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP HAD MOLD ON THE WALLS OF THE CUP. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853354 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP URINE COLLECTION DEVICE JTW BECTON, DICKINSON & CO. 5182571

    Patients

    Seq Age Sex Outcome Treatment
    1 Other