BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE

    MDR report key: 8237729 · Received January 10, 2019

    Report

    Report Number
    1917413-2018-04145
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 31, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSL
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR COLLAPSED TUBES WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND COLLAPSED TUBES WAS OBSERVED. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR COLLAPSED "TUBES" WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS CONDUCTED AND COLLAPSED OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBES 12 TUBES WERE BOWED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BEFORE USE OF THE BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBES 12 TUBES WERE BOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26280 BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE TRANSPORT CULTURE MEDIUM JSL BECTON, DICKINSON & CO. 8011880

    Patients

    Seq Age Sex Outcome Treatment
    1 Other