BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 11709093 · Received April 22, 2021

    Report

    Report Number
    1917413-2021-00311
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 30, 2021
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 5 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 90 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF FOREIGN MATTER WAS NOT 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. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE NURSES IN THE INFECTION DEPARTMENT USED OUR TUBES, THEY FOUND A PPT TUBE WITH A FOREIGN MATTER IN IT."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE NURSES IN THE INFECTION DEPARTMENT USED OUR TUBES, THEY FOUND A PPT TUBE WITH A FOREIGN MATTER IN IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603059 BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON & CO. (BROKEN BOW) 362788 0133206 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1