BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21265351 · Received January 29, 2025

    Report

    Report Number
    1917413-2025-00025
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    December 31, 2024
    Report Date
    June 27, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    UDI-DI
    50382903649582
    PMA / PMN Number
    K024240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3: DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 21-JAN-2025. INVESTIGATION SUMMARY: BD RECEIVED CUSTOMER RETURN SAMPLES (SENT DIRECTLY TO FRANKLIN LAKES) FOR INVESTIGATION. 100 RETENTION SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. ADDITIONALLY, 10 RETAIN SAMPLES WERE FUNCTIONALLY TESTED FOR STOPPER FUNCTION AND NO ISSUES WERE OBSERVED: NO ISSUES WITH CLOSURE ASSEMBLY BEING LOOSE OR SEPARATING AFTER FUNCTIONAL TESTING. ADDITIONALLY, FACTORS THAT MAY CONTRIBUTE TO STOPPER FUNCTION WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. THE ADDITIONAL TESTING WAS PERFORMED AT FRANKLIN LAKES: BOTH CUSTOMER¿S SAMPLES AND RETAINED SAMPLES FROM LOT# 4043778, EXP AUG 31, 2025, WERE TESTED TO CHARACTERIZE STOPPER PULL-OUT FORCE, AND BOTH SAMPLES PASSED BD PERFORMANCE REQUIREMENTS WITH NO STOPPER SHIELD SEPARATION. 8 CONTAMINATED SAMPLES WERE ALSO SENT FROM THE CUSTOMER, BUT LOT NUMBER CANNOT BE IDENTIFIED DUE TO DOUBLE LABELLING (CUSTOMER¿S LABEL OVER BD LABEL). BD DOES NOT HAVE A PROCEDURE TO TEST CONTAMINATED SAMPLES, SO THESE SAMPLES WERE NOT TESTED. DESIGN OF EXPERIMENTS WERE PERFORMED TO STUDY POTENTIAL FACTORS INFLUENCING THE STOPPER PULL-OUT AT THE CUSTOMER'S SITE. LOT # 3227753 (EXP FEB 28, 2025) AND LOT # 4212945 (EXP JAB 31, 2026) FROM THE CUSTOMER¿S SITE, A FRESH LOT (LOT #4346731, EXP JUN 30, 2026) PULLED FROM BD DISTRIBUTION CENTER AND A COMPETITOR¿S LOT WERE TESTED IN THE STUDY. INVESTIGATION CONCLUSION: BD AND COMPETITOR¿S TUBE HAVE SIMILAR RANGE OF PULLOUT FORCE WHILE BD HAS A TIGHTER CONFIDENCE INTERVAL. LOT # 4212945 HAS A LOWER PULLOUT FORCE, WHILE IT REMAINS WITHIN BD SPECIFICATION. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS ON THIS LOT AS OF APRIL 2, 2025. SLIGHTLY OFF-CENTERED ALIGNMENT AND HIGHER RECAP FORCE FROM THE INSTRUMENT COULD MAKE LOT #4212945 PERFORM SUB-OPTIMALLY. 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 STOPPER FUNCTION/LOOSE STOPPER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED DURING USE OF BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, 1 TUBE WAS NOT RESEATED ON THEIR AUTOMATED INSTRUMENT (COPAN WASP) AND THE CAP WAS LOOSE. A LAB ASSISTANT PICKED UP THE TUBE BY THE CAP AND THE TUBE FELL ON THE FLOOR AND URINE SPLASHED ON THEIR EAR. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED DURING USE OF BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, 1 TUBE WAS NOT RESEATED ON THEIR AUTOMATED INSTRUMENT (COPAN WASP) AND THE CAP WAS LOOSE. A LAB ASSISTANT PICKED UP THE TUBE BY THE CAP AND THE TUBE FELL ON THE FLOOR AND URINE SPLASHED ON THEIR EAR. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751915 BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM BECTON, DICKINSON & CO. (BROKEN BOW) 4043778 50382903649582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown