BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 9582684 · Received January 13, 2020

    Report

    Report Number
    1024879-2019-02251
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 23, 2019
    Report Date
    June 5, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD ACKNOWLEDGES THE CUSTOMER'S EXPERIENCE REGARDING THE INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WITH THE INCIDENT LOT. BD TECHNICAL SERVICES PROVIDED TROUBLESHOOTING WITH THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED AFTER USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT IS REPORTED CUSTOMER EXPERIENCED ELEVATED POTASSIUM RESULTS. CUSTOMER REPORTED HAVING ELEVATED POTASSIUM RESULTS USING BD GOLD TOP SST TUBE FOR THE PAST SIX MONTHS."

    Additional Manufacturer Narrative · 1

    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 #: 9143677. MEDICAL DEVICE EXPIRATION DATE: 2020-05-31. DEVICE MANUFACTURE DATE: 2019-05-23. MEDICAL DEVICE LOT #: 9196152. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2019-07-15. 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 THAT ERRONEOUS RESULTS OCCURRED AFTER USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT IS REPORTED CUSTOMER EXPERIENCED ELEVATED POTASSIUM RESULTS. CUSTOMER REPORTED HAVING ELEVATED POTASSIUM RESULTS USING BD GOLD TOP SST TUBE FOR THE PAST SIX MONTHS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47426 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE. H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other