BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COMPLETE CUP KIT

    MDR report key: 15538821 · Received October 4, 2022

    Report

    Report Number
    1917413-2022-00620
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    September 27, 2022
    Report Date
    October 14, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    PMA / PMN Number
    K024240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED 2 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTOS SHOW PRODUCT IN THE PACKAGING, THE CUSTOMER¿S FAILURE MODES OF DECAPPING AND OTHER ARE NOT SEEN IN THE PHOTOS. THE INSTRUCTIONS FOR USE STATE THAT REINSERTION OF THE CLOSURE IS TO REPLACE CLOSURE OVER TUBE, TWIST AND PUSH DOWN FIRMLY UNTIL STOPPER IS FULLY RESEATED. COMPLETE REINSERTION OF THE STOPPER IS NECESSARY FOR THE CLOSURE TO REMAIN SECURELY ON THE TUBE DURING HANDLING. ADDITIONALLY, 5 PRODUCTION LOT IN-HOUSE RETENTION TUBES FROM THE BD INVENTORY WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED AND THE ISSUE OF DECAPPING WAS NOT OBSERVED. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODES OF DECAPPING AND OTHER BASED ON THE INVESTIGATION COMPLETED. NO SAMPLES WERE RECEIVED, AND THE DEFECT WAS NOT OBSERVED IN THE RETENTION SAMPLE TESTING. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT CUSTOMER STATES THAT SAMPLE CONTAINER IS NOT SEALED PROPERLY. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BD REP IS REPORTING DEFECT WITH THE URINE SAMPLE CONTAINER NOT SEALED PROPERLY FOR CATALOG 364957, LOT #1278007.¿

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT CUSTOMER STATES THAT SAMPLE CONTAINER IS NOT SEALED PROPERLY. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BD REP IS REPORTING DEFECT WITH THE URINE SAMPLE CONTAINER NOT SEALED PROPERLY FOR CATALOG 364957, LOT #1278007.¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855431 BD VACUTAINER® URINE COMPLETE CUP KIT TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. (BROKEN BOW) 1278007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown