BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 15851975 · Received November 23, 2022

    Report

    Report Number
    9617032-2022-01183
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    November 7, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 24 RETENTION SAMPLES (12 FROM EACH INDICATED LOT) FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO STOPPER PULL OUT (STOPPER SEPARATION) AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE STOPPER PULL OUT (STOPPER SEPARATION) . BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2150167. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2022-05-30. MEDICAL DEVICE LOT #: 2145930. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2022-05-25. 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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE THE CAPS WERE BROKEN.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FOR A COUPLE OF WEEKS NOW WE HAVE SEEN PROBLEMS THAT THE CAPS OF SAMPLE TUBES GOES INTO TWO PIECES AFTER DECAPPING ON OUR LAB AUTOMATION. THIS CAUSE A LOT OF TROUBLE FOR US WHEN/IF THE TUBES COMES INTO OUR ANALYZE MACHINES. THERE HAVE BEEN SEVERAL PROBE CRASHES AND OTHER PROBLEMS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE THE CAPS WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FOR A COUPLE OF WEEKS NOW WE HAVE SEEN PROBLEMS THAT THE CAPS OF SAMPLE TUBES GOES INTO TWO PIECES AFTER DECAPPING ON OUR LAB AUTOMATION. THIS CAUSE A LOT OF TROUBLE FOR US WHEN/IF THE TUBES COMES INTO OUR ANALYZE MACHINES. THERE HAVE BEEN SEVERAL PROBE CRASHES AND OTHER PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314356 BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown