BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® C&S PRESERVATIVE URINE TUBE

    MDR report key: 9240212 · Received October 25, 2019

    Report

    Report Number
    1917413-2019-02254
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 10, 2019
    Report Date
    November 7, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    UDI-DI
    50382903649513
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS AND SAMPLES WERE EVALUATED AND IT WAS OBSERVED THAT THE ADDITIVE WAS IN LIQUID FORM. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® C&S PRESERVATIVE URINE TUBES EXPERIENCED DISCOLORED/ABNORMAL ADDITIVE FORM WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 364951, BATCH NO. 9220404. PER EMAIL: WE JUST RECEIVED 3 CASES OF 364951 URINE C&S PRESERVATIVE. THE TUBES CAME WITH THE WHITE PRESERVATIVE IN LIQUID FORM INSTEAD OF POWDER.

    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

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® C&S PRESERVATIVE URINE TUBES EXPERIENCED DISCOLORED/ABNORMAL ADDITIVE FORM WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 364951, BATCH NO. 9220404. PER EMAIL: WE JUST RECEIVED 3 CASES OF 364951 URINE C&S PRESERVATIVE. THE TUBES CAME WITH THE WHITE PRESERVATIVE IN LIQUID FORM INSTEAD OF POWDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037095 BD VACUTAINER® C&S PRESERVATIVE URINE TUBE TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. (BROKEN BOW) 9220404 50382903649513

    Patients

    Seq Age Sex Outcome Treatment
    1 Other