BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9667287 · Received February 4, 2020

    Report

    Report Number
    1024879-2020-00057
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 14, 2020
    Report Date
    February 26, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR GEL AIRBUBBLES WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND GEL AIRBUBBLES WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD TUBE SST HAD AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LAKES CAMPUS. WE¿VE HAD A SPATE OF MARKETED SST TUBES THAT HAVE VOIDS AND BUBBLES IN THE GEL. THE TUBES IN THIS INSTANCE WERE STERILIZED TWICE USING THE MAXIMUM DOSE ALLOWED IN THE IFU. FURTHER, THEY UNDERWENT ¿ACCELERATED AGING¿ THAT MAY OR MAY NOT HAVE BEEN THE CAUSE OF THE VOIDS. SHOULD WE SUBMIT A REPORT VIA THE STANDARD COMPLAINT PROCESS?"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. ADDITIONAL LOT NUMBER: 9242157; ADDITIONAL EXPIRATION DATE: 2020-08-31. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. ADDITIONAL MANUFACTURE DATE: 2019-08-30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD TUBE SST HAD AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LAKES CAMPUS. WE¿VE HAD A SPATE OF MARKETED SST TUBES THAT HAVE VOIDS AND BUBBLES IN THE GEL. THE TUBES IN THIS INSTANCE WERE STERILIZED TWICE USING THE MAXIMUM DOSE ALLOWED IN THE IFU. FURTHER, THEY UNDERWENT ¿ACCELERATED AGING¿ THAT MAY OR MAY NOT HAVE BEEN THE CAUSE OF THE VOIDS. SHOULD WE SUBMIT A REPORT VIA THE STANDARD COMPLAINT PROCESS?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132267 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 9254072 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other