BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 15825814 · Received November 18, 2022

    Report

    Report Number
    9617032-2022-01149
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    November 2, 2022
    Report Date
    November 23, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION SUMMARY: BD RECEIVED 1 PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS INVESTIGATION. AN EVALUATION OF THE PHOTOGRAPH INDICATED A STOPPER INSIDE THE TUBE WITHOUT A HEMOGUARD SHIELD. ADDITIONALLY, 24 RETAINED TUBES FROM THE SAME LOT NUMBERS OF THE BD INVENTORY WERE VISUALLY EVALUATED AND FUNCTIONALLY TESTED AND THE ISSUE OF DECAPPING WAS NOT OBSERVED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE FROM THE PHOTOGRAPH PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    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: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 2143156. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 2145930. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE THERE WAS A BROKEN CAP. 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. WE HAVE SEEN THIS PROBLEM ON DIFFERENT KIND OF TUBES BUT THE ONES THAT I´M SURE OF IS YOUR PART NR: 367525 AND 368497. THIS CAUSED 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 (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE THERE WAS A BROKEN CAP. 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. WE HAVE SEEN THIS PROBLEM ON DIFFERENT KIND OF TUBES BUT THE ONES THAT I´M SURE OF IS YOUR PART NR: 367525 AND 368497. THIS CAUSED 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
    321212 BD VACUTAINER® K2E (EDTA) 18.0MG 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