BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 18366685 · Received December 20, 2023

    Report

    Report Number
    9617032-2023-01828
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 22, 2023
    Report Date
    December 28, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903684977
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 20-DEC-2023 . H.6. INVESTIGATION SUMMARY: BD RECEIVED 100 SAMPLES FROM EACH LOT NUMBER 3180377; 3247739 AND 1 PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. EVALUATION OF THE PHOTOGRAPH DID CONFIRM LOW BLOOD VOLUME IN THE TUBES. 20 RETURNED SAMPLES FROM EACH LOT NUMBER PROVIDED WERE DRAW-TESTED WITH DEIONIZED WATER. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 40 TUBES DREW WITHIN SPECIFICATION. BD WAS ABLE TO CONFIRM CUSTOMERS¿ INDICATED FAILURE MODE BASED ON THE PHOTO PROVIDED, HOWEVER TESTING RETURNED SAMPLES DID NOT CONFIRM THE REPORTED DEFECT. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3247739 D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025 H.4. DEVICE MANUFACTURE DATE: 04-SEP-2023 D.4. MEDICAL DEVICE LOT #: 3180377 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024 H.4. DEVICE MANUFACTURE DATE: 29-JUN-2023.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THEY UNDERFILLED. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THEY UNDERFILLED. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084941 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3180377 00382903684977

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown