BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 21558740 · Received March 10, 2025

    Report

    Report Number
    9617032-2025-00337
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 11, 2025
    Report Date
    February 18, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903684985
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4171570. D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 19-JUN-2024. INVESTIGATION SUMMARY: BD RECEIVED THREE (3) PHOTOS FOR INVESTIGATION. THE EVALUATION OF THESE PHOTOS INDICATED UNDERFILL. A TOTAL OF 40 RETAINED SAMPLES, 20 FROM EACH LOT NUMBER, WERE TESTED WITH DEIONIZED WATER, AND IT WAS DETERMINED THAT ALL 40 TUBES MET SPECIFICATION. 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 LOTS 3279880 AND 4171570, FOR THE INDICATED FAILURE MODE: UNDERFILL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED ACROSS TWO LOT NUMBERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197216 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3279880 30382903684985

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown