BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9354954 · Received November 21, 2019

    Report

    Report Number
    1024879-2019-01993
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    November 1, 2019
    Report Date
    December 18, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: TYPE OF REPORTABLE EVENTS: SERIOUS INJURY. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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.

    Description of Event or Problem · 0

    MATERIAL NO. 367986 BATCH NO. 9143650. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES A TUBE CAP POPPED OFF AND SPLASHED AN EMPLOYEES FACE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS JUST WONDERING IF THERE WERE ANY DEFECT REPORTED ON THIS LOT? WE HAD A TUBE CAP POP OFF AND SPLASH IN EMPLOYEES FACE:

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    MATERIAL NO. 367986, BATCH NO. 9143650. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES A TUBE CAP POPPED OFF AND SPLASHED AN EMPLOYEES FACE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS JUST WONDERING IF THERE WERE ANY DEFECT REPORTED ON THIS LOT? WE HAD A TUBE CAP POP OFF AND SPLASH IN EMPLOYEES FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154417 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9143650 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other