BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD KIESTRA¿ INOQULA+¿ TLA

    MDR report key: 9266940 · Received November 1, 2019

    Report

    Report Number
    3010141591-2019-00203
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472139
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH THE COVER OF THE BARCODA PRINTER. THE COVER HAD A PROBLEM WITH THE GAS SPRINGS AND WOULD NOT STAY OPEN PROPERLY. THIS CAUSED A LAB STAFF HIT HIS HEAD ON THE COVER. THERE WAS NO BLEEDING OR BLOOD EXPOSURE BUT THE INJURY WAS A CONCUSSION. THE LAB STAFF WENT TO THE EMERGENCY WARD AND WAS EXAMINED, DISCHARGED AFTERWARDS AND WAS TEMPORARILY ON SICK LEAVE. AFTER THE INCIDENT THE GAS SPRINGS WERE REPLACED WHAT SOLVED THE PROBLEM. THE BARCODA WAS FULLY FUNCTIONAL AGAIN AND RUNNING ROUTINE WORKLOAD. THE INVOLVED INSTRUMENT WAS INSTRUMENT BD KIESTRA INOQULA WCA, MATERIAL NUMBER 447204, SERIAL NUMBER (B)(4). BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE. INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED THAT THE GAS SPRINGS ON THE COVER OF THE BARCODA PRINTER WERE NO MORE HOLDING THE COVER FULLY OPEN. A LAB STAFF HAD HIT HIS HEAD AGAINST THE COVER RESULTING IN A CONCUSSION. THE LID COULD COME DOWN BECAUSE THE SUPPORT STRENGTH OF THE GAS SPRINGS WAS REDUCED DUE TO REDUCED PRESSURE PROBABLY DUE TO WEARING. THE CUSTOMER COULD CONTINUE WITH PROCESSING SAMPLES. AS SOON AS POSSIBLE AFTER THE INCIDENT THE OLD GAS SPRINGS WERE REPLACED WITH NEW ONES. THE REPLACING GAS SPRINGS THAT WERE TEMPORARILY USED TO KEEP THE COVER IN THE OPENED POSITION WERE 300N WHILE THE ORIGINAL GAS SPRINGS ON THE BARCODA SHOULD BE 50N. THIS MADE THE COVER A LITTLE HARD TO GET DOWN BUT THE COVER DID NOT FALL DOWN ANYMORE. NEW 50N GAS SPRINGS WERE ORDERED AND PLACED ONCE DELIVERED. THIS SOLVED THE PROBLEM. A MANUFACTURER'S INCIDENT REPORT ON THIS ISSUE HAS BEEN ISSUED TO THE DANISH MEDICINES AGENCY (DMA) WITH REFERENCE NUMBER (B)(4). THE ISSUE HAS ALSO BEEN REPORTED TO THE FDA IN THE US. THIS INCIDENT HAS BEEN INCLUDED IN CAPA (B)(4). AS AN IMMEDIATE ACTION IN THIS CAPA THE REGIONS HAVE BEEN INFORMED TO REPLACE THE BARCODA HOOD GAS SPRINGS WHICH ARE OLDER THAN THE FOUR YEARS OF LIFETIME. A SERVICE BULLETIN, BDDSFSSB6968-46 ¿BARCODA HOOD GAS SPRING REPLACEMENT¿, HAS BEEN ISSUED THEREFORE. THE ACTIONS IN THIS BULLETIN APPLIES TO ALL BARCODA¿S FOR EACH CONFIGURATION (STANDALONE, WCA, TLA). ALSO AN AWARENESS EMAIL HAS BEEN SEND TO THE REGIONS THAT THEY HAVE TO START REPLACING THE GAS SPRINGS. THE RISK OF THIS ISSUE IS ADDRESSED AS SEVERITY 3 IN RISK MANAGEMENT DOCUMENT ¿HAZARD ANALYSIS FOR INOQULA¿, BALTRM-INOQULA-APH, REVISION 10. ROOT CAUSE DESCRIPTION: THE CAUSE OF THE ISSUE IS PRESSURE LEAKING GAS SPRINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TLA, THE CUSTOMER WAS HAVING ISSUES WITH THE COVER OF THE BARCODA PRINTER AND SUSTAINED AN INJURY. THE COVER HAD A PROBLEM WITH THE GAS SPRINGS CAUSING IT TO NOT STAY OPEN PROPERLY, HITTING A LAB STAFF EMPLOYEE ON THE HEAD. THERE WAS NO BLEEDING OR BLOOD EXPOSURE. THE LAB STAFF WENT TO THE EMERGENCY WARD AND IT WAS DETERMINED THEY HAD A CONCUSSION. THE STAFF MEMBER WAS ON SICK LEAVE FOR SEVERAL DAYS, AND HAS NOW RETURNED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061017 BD KIESTRA¿ INOQULA+¿ TLA MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION UNKNOWN 00382904472139

    Patients

    Seq Age Sex Outcome Treatment
    1 Other