BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 8962887 · Received September 4, 2019

    Report

    Report Number
    9617032-2019-00993
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 16, 2019
    Report Date
    February 21, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679572
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. NEUTROPHIL ANALYSIS IS NOT POSSIBLE ON SERUM (SST TUBES). 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 DURING USE OF THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WERE ERRONEOUS RESULTS THERE WERE SEVERAL CASES OF NEUTROPENIA. THIS OCCURRED ON 100 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED THE MESSAGE FROM THE STUDY TEAM THAT HAS IDENTIFIED SEVERAL CASES OF NEUTROPENIA THAT THEY WOULD LIKE US TO INVESTIGATE. THEY PROVIDED US WITH THE FOLLOWING INFORMATION ABOUT THE ARTICLES: BD 367957: 3.5 ML VACUTAINER SERUM GEL (EUROFINS ART. 1410301082), SEE HEREAFTER THE LOT NUMBERS: 8338716, 9007541, 9030818, 9057554, 9063876.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8338716. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2018-12-04. MEDICAL DEVICE LOT #: 9007541. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-01-07. MEDICAL DEVICE LOT #: 9030818. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2019-01-30. MEDICAL DEVICE LOT #: 9057554. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2019-02-26. MEDICAL DEVICE LOT #: 9063876. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2019-03-04. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WERE ERRONEOUS RESULTS THERE WERE SEVERAL CASES OF NEUTROPENIA. THIS OCCURRED ON 100 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED THE MESSAGE FROM THE STUDY TEAM THAT HAS IDENTIFIED SEVERAL CASES OF NEUTROPENIA THAT THEY WOULD LIKE US TO INVESTIGATE. THEY PROVIDED US WITH THE FOLLOWING INFORMATION ABOUT THE ARTICLES: BD 367957: 3.5 ML VACUTAINER SERUM GEL (EUROFINS ART. 1410301082), SEE HEREAFTER THE LOT NUMBERS: 8338716, 9007541, 9030818, 9057554, 9063876.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755143 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367957 SEE H.10 50382903679572

    Patients

    Seq Age Sex Outcome Treatment
    1 Other