BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 18940395 · Received March 20, 2024

    Report

    Report Number
    1917413-2024-00219
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 2, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903627951
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MULTIPLE LOTS INVOLVED: D4. MEDICAL DEVICE LOT #: 3163623 D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2024 H4. DEVICE MANUFACTURE DATE: 12-JUN-2023 D4. MEDICAL DEVICE LOT #: 3194693 D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024 H4. DEVICE MANUFACTURE DATE: 13-JUL-2023 D4. MEDICAL DEVICE LOT #: 3222673 D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2024 H4. DEVICE MANUFACTURE DATE: 10-AUG-2023 H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE OF GEL AIR BUBBLES WAS OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE GEL AIR BUBBLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF FEBRUARY 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE WERE AIR BUBBLES IN THE GEL. THE TUBES WERE DISCARDED. AFFECTED QUANTITIES: 3163623 , QTY 67 3194693, QTY 211 3222673, QTY 62

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE WERE AIR BUBBLES IN THE GEL. THE TUBES WERE DISCARDED. AFFECTED QUANTITIES: (B)(6) QTY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410992 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H10 30382903627951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown