BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 22003931 · Received May 12, 2025

    Report

    Report Number
    1024879-2025-00640
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 15, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679851
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3: DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 02-MAY-2025. INVESTIGATION SUMMARY: FOR LOT 4232450, BD RECEIVED 23 SAMPLES FOR INVESTIGATION. THESE SAMPLES UNDERWENT VARIOUS VISUAL INSPECTIONS: 14 FAILED FOR COLLAPSED TUBES; 4 FAILED FOR IMPROPER ASSEMBLY; 5 FAILED FOR FM; 22 FAILED FOR MOLDED PART DEFECTS; 14 FAILED FOR DAMAGES. ADDITIONALLY, 10 SAMPLES WERE INSPECTED FOR BRITTLENESS, WITH NONE FAILING. FURTHERMORE, 5 CUSTOMER SAMPLES UNDERWENT A FUNCTIONAL TEST FOR DRAW VOLUME, ALL OF WHICH WERE WITHIN SPECIFICATION. FOR RETAINED SAMPLES, 20 UNDERWENT A FUNCTIONAL TEST FOR DRAW VOLUME, ALL OF WHICH WERE WITHIN SPECIFICATION. ADDITIONALLY, 30 RETAIN SAMPLES WERE INSPECTED FOR ALL VISUAL DEFECTS, WITH NONE FAILING. FURTHERMORE, 10 WERE INSPECTED FOR BRITTLENESS, WITH NONE FAILING. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 4232450, FOR THE INDICATED FAILURE MODES: COLLAPSE, DAMAGED, UNDERFILL, FOREIGN MATTER, IMPROPER ASSEMBLY AND MOLDING DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K230855. 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 · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372097 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4232450 30382903679851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown