BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10097209 · Received May 28, 2020

    Report

    Report Number
    1917413-2020-00465
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 5, 2020
    Report Date
    June 25, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-06-01. H.6. 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 MOLDING DEFECT WITH THE INCIDENT LOT WAS OBSERVED. THE CUSTOMER SAMPLE WAS EXPIRED ON 2020-04-30; THEREFORE, NO FURTHER TESTING COULD BE COMPLETED. 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 BY BD R&D THAT THE STOPPER HAD A MOLDING DEFECT WHICH LED TO LOW DRAW WITH A BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I RECENTLY WERE NOTIFIED OF A DRAW VOLUME FAILURE DUE TO A STOPPER DEFECT. AS THESE SAMPLES WERE COLLECTED FROM RETAINS, WE WANTED TO REACH OUT TO YOU TO CONFIRM IF THIS IS A COMPLAINT OR NOT.

    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 BY BD R&D THAT THE STOPPER HAD A MOLDING DEFECT WHICH LED TO LOW DRAW WITH A BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I RECENTLY WERE NOTIFIED OF A DRAW VOLUME FAILURE DUE TO A STOPPER DEFECT. AS THESE SAMPLES WERE COLLECTED FROM RETAINS, WE WANTED TO REACH OUT TO YOU TO CONFIRM IF THIS IS A COMPLAINT OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558574 BD VACUTAINER BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE TRANSPORT CULTURE MEDIUM JSL BECTON, DICKINSON & CO. (BROKEN BOW) 8276572

    Patients

    Seq Age Sex Outcome Treatment
    1 Other