BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 21345152 · Received February 10, 2025

    Report

    Report Number
    9617032-2025-00124
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 19, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903630791
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD RECEIVED ONE (1) PHOTO FOR INVESTIGATION. A TOTAL OF 60 SAMPLES, 20 RETAINED SAMPLES FROM EACH LOT NUMBER, UNDERWENT FUNCTIONAL TESTS WITH DEIONIZED WATER. IT WAS DETERMINED THAT ALL 60 TUBES WERE WITHIN 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 4198908, 4241813 AND 4267659, 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.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4198908 D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025 H4. DEVICE MANUFACTURE DATE: 16-JUL-2024 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT #: 4241813 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025 H4. DEVICE MANUFACTURE DATE: 28-AUG-2024 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES (15 PER DAY) ARE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES (15 PER DAY) ARE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657331 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 4267659 30382903630791

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown