BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA INOQULA

    MDR report key: 13026376 · Received December 17, 2021

    Report

    Report Number
    3010141591-2021-00003
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    November 20, 2021
    Report Date
    November 30, 2021
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: UNKNOWN. "THE FIELD SERVICE ENGINEER NOTICED (WHILE BEING ONSITE FOR ANOTHER REPAIR ((B)(4)), ON THE BD KIESTRA INOQULA (MATERIAL # 447202 (B)(4)) THAT BOTH GAS SPRING WHICH HOLD THE HOOD OF THE BARCODA PRINTER WERE NOT FIRMLY SECURING THE HOOD. THE HOOD WOULD NOT STAY OPEN WHEN IT IS OPEN TO CLEAR PLATES AND LABELS. THE FIELD SERVICE ENGINEER REPLACED THE GAS SPRING ON THE HOOD OF THE BARCODA PRINTER. THE FIELD SERVICE ENGINEER HAS USED THE PART # 446072 - GAS SPRING 08-19 80 205 100N AND CLEVIS (FROM THE ENSURA CABINET). THE GAS SPRINGS WERE TESTED WITHOUT ERRORS, AND THE SYSTEM WAS RETURNED TO THE CUSTOMER FOR REGULAR USE. THE INOQULA STAND-ALONE WAS LEFT FUNCTIONING CORRECTLY AND OPERATIONAL. THE ISSUE THAT THE GAS SPRINGS OF THE BARCODA PRINTER WERE FAULTY WAS CONFIRMED BY THE FIELD SERVICE ENGINEER. CAPA (B)(4) WAS CREATED FOR THE ISSUE THAT THE GAS SPRINGS OF THE INOQULA AND BARCODA DO NOT SUPPORT THE HOOD ANYMORE. THIS PR HAS BEEN REPORTED TO THE CAPA OWNER OF CAPA (B)(4) - INOQULA - BARCODA HOOD DROPPED ON USERS¿ HAND (MINOR INJURY) FOR FURTHER INVESTIGATION. THE CAPA WAS CREATED PREVIOUSLY WITH THIS ISSUE AND THAT THIS CASE DOES NOT CREATE A NEW CAPA. DESIGN HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA, THE GAS SPRINGS ON THE BARCODA PRINTER FAILED TO KEEP THE HOOD/LID OPEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BOTH GAS SPRINGS ON HOOD OF THE BARCODA PRINTER NOT HOLDING THE HOOD. CUSTOMER PROBLEM: FSE WAS ON-SITE FOR ((B)(4)), AND NOTICED THE BOTH GAS SPRING WHICH HOLD THE HOOD OF THE BARCODA PRINTER IS NOT FIRMLY SECURING THE HOOD. THEREFORE, THE HOOD WOULD NOT STAY OPEN WHEN LAB TECH OPEN TO CLEAR PLATES AND LABELS. IT WOULD CONSIDER NOT SAFE FOR LAB TECH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921731 BD KIESTRA INOQULA N/A JTC BD KIESTRA LAB AUTOMATION 447202 NA 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown