BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE

    MDR report key: 18486219 · Received January 10, 2024

    Report

    Report Number
    1917413-2023-01332
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JTW
    UDI-DI
    30382903649922
    PMA / PMN Number
    K790366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. DEVICE AVAILABLE FOR EVALUATION: YES RETURNED TO MANUFACTURER ON: 26-DEC-2023 INVESTIGATION SUMMARY: BD RECEIVED 2 RETURNED SAMPLES AND 5 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. VISUAL EXAMINATION OF THE SAMPLES AND PHOTOS REVEALED DEFECTIVE STOPPER MOLDING. DEVICE HISTORY RECORD REVIEW OF REPORTED INCIDENT LOT DETERMINED ALL PRODUCT RELEASE REQUIREMENTS WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING PRODUCT MANUFACTURE. THIS COMPLAINT HAS BEEN CONFIRMED FOR DEFECTIVE STOPPER MOLDING. BD WAS UNABLE TO IDENTIFY A ROOT CAUSE FOR INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D2B: MEDICAL DEVICE TYPE: KDT. H3. 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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE A DEFECT IN THE MOLDING OF STOPPER WAS FOUND BY THE USER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE A DEFECT IN THE MOLDING OF STOPPER WAS FOUND BY THE USER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552600 BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER JTW BECTON, DICKINSON & CO. (BROKEN BOW) 3016611 30382903649922

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown