BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9354778 · Received November 21, 2019

    Report

    Report Number
    1024879-2019-01989
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    October 26, 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

    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

    IT WAS REPORTED THAT THE STOPPER POPPED OUT OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE AFTER USE, SPLATTERING BLOOD "EVERYWHERE". THE BLOOD MADE CONTACT WITH THE EMPLOYEE'S FACE AND SCRUBS, AND TESTS WERE UNDERGONE TO ENSURE THERE WAS NO EXPOSURE TO DISEASES. THE EVENT OF THE STOPPER POPPING OUT OF THE TUBE OCCURRED ON 2 SEPARATE OCCASIONS, WITH ONE INCIDENT FROM LOT# 9172629, AND ONE FROM AN UNSPECIFIED LOT; HOWEVER, THE DATES AND/OR PATIENT INFORMATION FOR THESE OCCURRENCES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CALLER STATED AFTER THE EMPLOYEE WAS FINISHED DRAWING BLOOD, THEY PLACED THE TUBES ON THE COUNTER AND ATTACHED A LABEL TO THE TUBE. THE TOP OF THE TUBE THEN POPPED OFF AND SPLATTERED BLOOD EVERYWHERE. THEY STATED THE EMPLOYEE WAS EXPOSED TO THE BLOOD ON THEIR FACE AND THEIR SCRUBS. THE EMPLOYEE UNDERWENT BLOOD TESTS TO ENURE THEY WERE NOT EXPOSED TO ANY DISEASES."

    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 #: 9172629. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-06-21 . MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 THE STOPPER POPPED OUT OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE AFTER USE, SPLATTERING BLOOD "EVERYWHERE". THE BLOOD MADE CONTACT WITH THE EMPLOYEE'S FACE AND SCRUBS, AND TESTS WERE UNDERGONE TO ENSURE THERE WAS NO EXPOSURE TO DISEASES. THE EVENT OF THE STOPPER POPPING OUT OF THE TUBE OCCURRED ON 2 SEPARATE OCCASIONS, WITH ONE INCIDENT FROM LOT# 9172629, AND ONE FROM AN UNSPECIFIED LOT; HOWEVER, THE DATES AND/OR PATIENT INFORMATION FOR THESE OCCURRENCES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CALLER STATED AFTER THE EMPLOYEE WAS FINISHED DRAWING BLOOD, THEY PLACED THE TUBES ON THE COUNTER AND ATTACHED A LABEL TO THE TUBE. THE TOP OF THE TUBE THEN POPPED OFF AND SPLATTERED BLOOD EVERYWHERE. THEY STATED THE EMPLOYEE WAS EXPOSED TO THE BLOOD ON THEIR FACE AND THEIR SCRUBS. THE EMPLOYEE UNDERWENT BLOOD TESTS TO ENURE THEY WERE NOT EXPOSED TO ANY DISEASES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151914 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE SECTION H.10. 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention