BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE

    MDR report key: 9701807 · Received February 12, 2020

    Report

    Report Number
    1917413-2020-00110
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 22, 2020
    Report Date
    April 20, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    KDT
    UDI-DI
    50382903649926
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS WERE FOUND DURING USE WITH A BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT IS REPORTED BY CUSTOMER URINALYSIS INSTRUMENT ALERTED CRYSTALS BEING PRESENT IN SPECIMEN. THOUGH UPON MANUAL INSPECTION CUSTOMER CONFIRMED SPECIMEN HAD NO CRYSTALS PRESENT. "NOTIFICATION BY URINALYSIS INSTRUMENT OF PRESENCE OF CRYSTALS; WHEN EXAMINED MICROSCOPICALLY, NO CRYSTALS PRESENT. CUSTOMER USES ARKRAY AU4050 FOR URINALYSIS TESTING. THEY STARTED TRANSFERRING SPECIMENS IN THE UA DEPARTMENT TO THE UAP TUBE AND IMMEDIATELY RUNNING THEM ON THEIR INSTRUMENT. THEY STARTED RECEIVING CRYSTAL NOTIFICATIONS, REQUIRING THEM TO REVIEW THE SPECIMEN MICROSCOPICALLY, WHERE THEY THEN SAW NO CRYSTALS PRESENT." DURING THE SURVEY HE STATED THAT THE TIGER TOP TUBES FOR URINE SHOW CRYSTALS IN IT. THAT IS, IT SHOWS FALLS (+) POSITIVE FOR CRYSTALS. " 10 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 #: 9241980. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2019-08-29. MEDICAL DEVICE LOT #: 9184874. MEDICAL DEVICE EXPIRATION DATE: 2020-12-31. DEVICE MANUFACTURE DATE: 2019-07-03. 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 ERRONEOUS RESULTS WERE FOUND DURING USE WITH A BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "-IT IS REPORTED BY CUSTOMER URINALYSIS INSTRUMENT ALERTED CRYSTALS BEING PRESENT IN SPECIMEN. THOUGH UPON MANUAL INSPECTION CUSTOMER CONFIRMED SPECIMEN HAD NO CRYSTALS PRESENT. "NOTIFICATION BY URINALYSIS INSTRUMENT OF PRESENCE OF CRYSTALS; WHEN EXAMINED MICROSCOPICALLY, NO CRYSTALS PRESENT. CUSTOMER USES ARKRAY AU4050 FOR URINALYSIS TESTING. THEY STARTED TRANSFERRING SPECIMENS IN THE UA DEPARTMENT TO THE UAP TUBE AND IMMEDIATELY RUNNING THEM ON THEIR INSTRUMENT. THEY STARTED RECEIVING CRYSTAL NOTIFICATIONS, REQUIRING THEM TO REVIEW THE SPECIMEN MICROSCOPICALLY, WHERE THEY THEN SAW NO CRYSTALS PRESENT." DURING THE SURVEY HE STATED THAT THE TIGER TOP TUBES FOR URINE SHOW CRYSTALS IN IT. THAT IS, IT SHOWS FALLS (+) POSITIVE FOR CRYSTALS. " 10 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167028 BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER KDT BECTON, DICKINSON & CO. (BROKEN BOW) SEE. H.10 50382903649926

    Patients

    Seq Age Sex Outcome Treatment
    1 Other