BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUP

    MDR report key: 9716728 · Received February 17, 2020

    Report

    Report Number
    9617032-2020-00130
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 24, 2020
    Report Date
    April 17, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    KDW
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOUDINESS WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUPS LOOK DIRTY AND CLOUDY WITH A BD VACUTAINER® URINE COLLECTION CUP. THIS OCCURRED ON 30 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUPS LOOK LIKE DIRTY AND CLOUDY.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9148917. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2019-05-28. MEDICAL DEVICE LOT #: 9232652. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2019-08-20. " A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUPS LOOK DIRTY AND CLOUDY WITH A BD VACUTAINER® URINE COLLECTION CUP. THIS OCCURRED ON 30 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUPS LOOK LIKE DIRTY AND CLOUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181817 BD VACUTAINER® URINE COLLECTION CUP SPECIMEN TRANSPORT AND STORAGE CONTAINER KDW BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other