BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7083588 · Received December 5, 2017

    Report

    Report Number
    1917413-2017-00202
    Event Type
    Malfunction
    Date Received
    December 5, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD (B)(6) 2016. RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER OR 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MOLD 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
    861033 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP URINE COLLECTION CUP KDT BECTON, DICKINSON & CO. 5005665

    Patients

    Seq Age Sex Outcome Treatment
    1 Other