BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE

    MDR report key: 17364161 · Received July 20, 2023

    Report

    Report Number
    1917413-2023-00672
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    July 3, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JTW
    UDI-DI
    50382903649926
    PMA / PMN Number
    K790366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL? YES. D.10 RETURNED TO MANUFACTURER ON: 08-AUG-2023. INVESTIGATION SUMMARY: BD RECEIVED 18 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, THERE IS UNDERFILL OF AN UNSPECIFIED NUMBER OF TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS ADVISED THE TUBES ARE NOT FILLING PROPERLY WHEN INSERTED IN THE URINE COLLECTION CUP ¿ ITEM 364992, LOT 2200074, EXPIRY 2024/01/31."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, THERE IS UNDERFILL OF AN UNSPECIFIED NUMBER OF TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS ADVISED THE TUBES ARE NOT FILLING PROPERLY WHEN INSERTED IN THE URINE COLLECTION CUP ¿ ITEM 364992, LOT 2200074, EXPIRY 2024/01/31."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39143 BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER JTW BECTON, DICKINSON & CO. (BROKEN BOW) 364992 2200074 50382903649926

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown