BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7075026 · Received December 1, 2017

    Report

    Report Number
    1917413-2017-00200
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    April 4, 2016
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS K790366. IT IS CORRECTED TO READ EXEMPT.

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED APPROXIMATELY 200 SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER/MOLD ON URINE CUPS WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 CUSTOMERS¿ INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MOLDY APPEARANCE ON 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUPS. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853776 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP URINE COLLECTION CUP KDT BECTON, DICKINSON & CO. 5182571

    Patients

    Seq Age Sex Outcome Treatment
    1 Other