BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 17084581 · Received June 8, 2023

    Report

    Report Number
    1917413-2023-00508
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    December 30, 2022
    Report Date
    May 12, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 #: 2109020 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30 H4. DEVICE MANUFACTURE DATE: 2022-04-19 D4. MEDICAL DEVICE LOT #: 2166964 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30 H4. DEVICE MANUFACTURE DATE: 2022-06-15 D4. MEDICAL DEVICE LOT #: 2227082 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31 H4. DEVICE MANUFACTURE DATE: 2022-08-15 D4. MEDICAL DEVICE LOT #: 2200040 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31 H4. DEVICE MANUFACTURE DATE: 2022-07-19 D4. MEDICAL DEVICE LOT #: 2259022 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30 H4. DEVICE MANUFACTURE DATE: 2022-09-16 D4. MEDICAL DEVICE LOT #: 2292024 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31 H4. DEVICE MANUFACTURE DATE: 2022-10-19 H. 6 INVESTIGATION SUMMARY MATERIAL #: 362788 LOT/BATCH #: 2080603, 2109020, 2166964, 2227082, 22000040, 2259022, 2292024 BD HAD NOT RECEIVED SAMPLES, BUT 12 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CRACKED TUBES WAS OBSERVED. THE INSTRUCTIONS FOR USE (IFU) ON THE EVACUATED BLOOD COLLECTION SYSTEM STATES UNDER THE STORAGE FOR THE PRODUCT, STORE TUBES AT 4-25°C (39-77°F). 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 CRACKED TUBES BASED ON PHOTOS ONLY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG THERE WAS A CRACK TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBES BREAKING WHEN REMOVING TUBES FROM FREEZER FOR PACKAGING/SHIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427904 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 362788 2080603 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown