BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE

    MDR report key: 8793894 · Received July 16, 2019

    Report

    Report Number
    1917413-2019-01752
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    April 26, 2019
    Report Date
    August 7, 2019
    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: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. IT IS COMMONPLACE FOR VARIOUS TYPES OF CRYSTAL FORMATION TO BE NOTED IN REFRIGERATED URINE SPECIMENS. GUIDELINES RECOMMEND TESTING URINE WITHIN TWO HOURS OF COLLECTION. PRESERVATION OF URINE IS RECOMMENDED IF THAT IS NOT POSSIBLE. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 364992, BATCH NO. 8121514. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, "CALCIUM OXALATE CRYSTALS APPEARING IN URINALYSIS PRESERVATIVE TUBE." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OF 2. CALCIUM OXALATE CRYSTALS APPEARING IN URINALYSIS PRESERVATIVE TUBE.

    Additional Manufacturer Narrative · 1

    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

    (B)(4). IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, "CALCIUM OXALATE CRYSTALS APPEARING IN URINALYSIS PRESERVATIVE TUBE." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OF 2 . CALCIUM OXALATE CRYSTALS APPEARING IN URINALYSIS PRESERVATIVE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589183 BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER KDT BECTON, DICKINSON & CO. (BROKEN BOW) 8121514 50382903649926

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other