BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUP

    MDR report key: 9417488 · Received December 5, 2019

    Report

    Report Number
    9617032-2019-01398
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 19, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR CLOUDY CUPS WITH THE INCIDENT LOT WAS OBSERVED. THE CUSTOMER SAMPLES WERE TESTED AND NO ISSUES RELATING TO CLOUDY CUPS WERE OBSERVED AS ALL RESULTS DEMONSTRATED SATISFACTORY PERFORMANCE. 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. ADDITIONALLY, RESULTS FROM A CLINICAL STUDY INDICATED THAT CUPS MANUFACTURED WITH A CLOUDY APPEARANCE DEMONSTRATED NO STATISTICALLY SIGNIFICANT DIFFERENCES FOR NUMERIC ROUTINE URINALYSIS PARAMETERS WHEN COMPARED TO OTHER CUPS MANUFACTURED WITH A CLEAR APPEARANCE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD VACUTAINER® URINE COLLECTION CUP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "URINE CUPS HAS SOMETHING WHITISH/MISTY ON THE SIDES OF THE CUPS. (THEY LOOK DIRTY) URINE CUPS HAVE A MISTY/WHITISH LAYER ON THE SIDES OF THE CUPS. SEVERAL DIFFERENT LOT NUMBERS. THE CUSTOMER TESTED WITH WATER AND COMPARED WITH A "CLEAN" CUP AND FOUND A LOWER PH." 1000 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9177755, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2019-06-26. MEDICAL DEVICE LOT #: 9162580, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2019-06-11. MEDICAL DEVICE LOT #: 9197661, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2019-07-16. 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 FOREIGN MATTER OCCURRED BEFORE USE WITH A BD VACUTAINER® URINE COLLECTION CUP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, URINE CUPS HAS SOMETHING WHITISH/MISTY ON THE SIDES OF THE CUPS. (THEY LOOK DIRTY). URINE CUPS HAVE A MISTY/WHITISH LAYER ON THE SIDES OF THE CUPS. SEVERAL DIFFERENT LOT NUMBERS. THE CUSTOMER TESTED WITH WATER AND COMPARED WITH A "CLEAN" CUP AND FOUND A LOWER PH." 1000 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215605 BD VACUTAINER® URINE COLLECTION CUP SPECIMEN TRANSPORT AND STORAGE CONTAINER JKA BECTON, DICKINSON AND COMPANY (BD) SEE. H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other