BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9354975 · Received November 21, 2019

    Report

    Report Number
    1024879-2019-01991
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 1, 2019
    Report Date
    December 17, 2019
    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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: MEDICAL DEVICE EXPIRATION DATE: 2020-05-31. MEDICAL DEVICE LOT #: 9151833. DEVICE MANUFACTURE DATE: 2019-05-31.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD AN ADDITIVE ABNORMALITY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SST TUBES HAVE BEEN SHOWING DROPLETS OF ADDITIVE ATTACHED TO THE TUBE WALL, INSOLUBLE IN BIOLOGICAL MATERIAL EVEN PROCEEDING WITH HOMOGENIZATION AS RECOMMENDED BY THE MANUFACTURER. IT HAPPENED TO ALL GEL TUBES THEY USE BUT DID NOT SPECIFY BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD AN ADDITIVE ABNORMALITY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SST TUBES HAVE BEEN SHOWING DROPLETS OF ADDITIVE ATTACHED TO THE TUBE WALL, INSOLUBLE IN BIOLOGICAL MATERIAL EVEN PROCEEDING WITH HOMOGENIZATION AS RECOMMENDED BY THE MANUFACTURER. IT HAPPENED TO ALL GEL TUBES THEY USE BUT DID NOT SPECIFY BATCH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD AN ADDITIVE ABNORMALITY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SST TUBES HAVE BEEN SHOWING DROPLETS OF ADDITIVE ATTACHED TO THE TUBE WALL, INSOLUBLE IN BIOLOGICAL MATERIAL EVEN PROCEEDING WITH HOMOGENIZATION AS RECOMMENDED BY THE MANUFACTURER. IT HAPPENED TO ALL GEL TUBES THEY USE BUT DID NOT SPECIFY BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154406 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9151833 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other