BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBES

    MDR report key: 12204371 · Received July 21, 2021

    Report

    Report Number
    2243072-2021-01939
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 30, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM YOUR FACILITY FOR EVALUATION. ADDITIONALLY, WE WERE UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION IN ORDER TO IDENTIFY EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBES , THE DEVICE EXPERIENCED STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED CUSTOMER EXPERIENCED 2 OCCURRENCES OF STOPPERS POPPING OFF. DURING ONE OCCURRENCE AN EMPLOYEE WAS EXPOSED TO BLOOD. VERBIAGE RECEIVED: "ALERTING YOU TO A POTENTIAL ISSUE WITH THE BD VACUTAINER BLOOD COLLECTION TUBES WITH GREEN TOPS. A USER REPORTED PRESSURE BUILT UP DURING MIXING AND THE CAP FAILED SPRAYING THE USER IN THE FACE. THIS OCCURRED ON TWO SEPARATE OCCASIONS, (B)(6) AND (B)(6) AT THE KAISER PERMANENTE CAPITOL HILL/SEATTLE HOSPITAL. PRODUCT NAME: BD VACUTAINER BLOOD COLLECTION TUBE (GREEN). LOT NUMBER: B210136D, REF# 4540089. ANY HARM? YES, BLOOD SPLASH TO THE EYES. WHAT IS THE ISSUE YOU EXPERIENCED? AN URGENT CARE NURSE REPORTED LIGHTLY VIBRATING THE TUBE AFTER BLOOD DRAW TO MIX BLOOD PRODUCT. ONCE SHAKING STOPPED AND FINGER REMOVED FROM TOP, THE CAP BURST OFF AND BLOOD ERUPTED SPRAYING THE USER, WALL, AND CEILING. THE NURSE IS EXPERIENCED WITH BLOOD DRAWS AND HAS NOT PREVIOUSLY ENCOUNTERED ISSUES. NO ISSUES WITH SAME LOT FROM LAB USERS. SAMPLE AVAILABLE? YES, I BELIEVE THERE WERE SOME CLEAN TUBES FROM THE SAME LOT PRESERVED IN THE URGENT CARE AND LAB DEPARTMENTS." 07-JULY-2021 @ 3:45PM CST: I SPOKE WITH CUSTOMER WHOM CONFIRMED EMPLOYEE DID RECEIVE POST-EXPOSURE TESTING WITH NO ISSUES WITH ANY RESULTS. DATE OF EVENT FOR EXPOSURE WAS (B)(6) 2021. THIS WAS THE ONLY DATE EXPOSURE OCCURRED. NO OTHER INFORMATION AVAILABLE. EMPLOYEES WERE INVERTING THESE VACUTAINERS BY HAND WHEN STOPPER POPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104309 UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other