BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG

    MDR report key: 18507604 · Received January 12, 2024

    Report

    Report Number
    1917413-2023-01343
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 18, 2023
    Report Date
    February 6, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    50382903627993
    PMA / PMN Number
    K972075
    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 MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D2B: MEDICAL DEVICE TYPE: JKA & PJE. E1: INITIAL REPORTER FACILITY NAME: (B)(6). 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: NO SAMPLES AND 4 PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 362799, LOT NUMBER 3048739. VISUAL EXAMINATION OF THE PHOTOS WAS PERFORMED AND REVEALED ADDITIVE ABNORMALITY. THE TUBES HAVE LARGE DROPLETS OF ADDITIVE ON THE INSIDE WALL OF THE TUBE FROM RUNDOWN OF THE ADDITIVE WHEN ADDITIVE IS APPLIED ONTO THE INTERIOR WALLS OF THE BLOOD COLLECTION VESSEL VIA THE SPRAY COATING OF THE PRESCRIBED AMOUNT OF WATER-BASED SOLUTION. THE WATER IS THEN DRIED, LEAVING THE CHARACTERISTIC ¿MIST¿ DOT PATTERN OF RESIDUAL SOLUTION ON THE VESSEL WALL. IN RARE INSTANCES WHERE ASSEMBLY MACHINE MISALIGNMENTS OCCUR, ADDITIVE DISPENSE NOZZLES MAY NOT BE CENTERED WITHIN THE TUBES¿ OPENING AND THE NOZZLES¿ POSITION IS BIASED MORE TOWARDS ONE OF THE VESSELS¿ HEMISPHERES. IN SUCH INSTANCED, ONE SIDE (OR HEMISPHERE) OF THE TUBE VESSEL INTERIOR RECEIVED A HEAVIER COATING OF ADDITIVE SOLUTION, WHILE POINTS ON THE OPPOSING SIDE OF VESSEL RECEIVE A LIGHTER MISTING. LARGER DROPLETS OF THE SOLUTION IN CLOSE PROXIMITY TO ONE ANOTHER THAN TEND TO COALESCE, AND ONCE THE WATER IS DRIED, LEAVE BEHIND A WAFER LIKE DEPOSIT OF THE ADDITIVE. THIS ADDITIVE DEPOSIT VISUALLY STANDS OUT AS IT DOES NOT APPEAR LIKE THE TYPICAL DOT PATTERN FOR THIS TUBE TYPE. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS 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 IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THAT THE USER FOUND, PRIOR TO USE, TWO TUBES WITH ABNORMAL ADDITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THAT THE USER FOUND, PRIOR TO USE, TWO TUBES WITH ABNORMAL ADDITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826861 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON & CO. (BROKEN BOW) 3048739 50382903627993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown