BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ INOQULA+¿ TLA

    MDR report key: 14808398 · Received June 24, 2022

    Report

    Report Number
    3010141591-2022-00009
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 22, 2022
    Report Date
    August 15, 2022
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472139
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: NA.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY : THE CUSTOMER REPORTED ON THE BD KIESTRA INOQULA TLA (MATERIAL # 447213 - SERIAL # (B)(6). THAT THE HOOD GAS SPRINGS NEEDED REPLACEMENT. THE BARCODA HOOD DID NOT STAY OPEN. THE FIELD SERVICE ENGINEER FIRST SWAPPED THE HOOD GAS SPRINGS FROM THE BARCODA 2 TO THE BARCODA 1 UNTIL THE NEW SPRINGS ARRIVED. THE NEW GAS SPRINGS (MATERIAL NUMBER 446064) WERE INSTALLED AND TESTED WITHOUT ISSUES FOUND. A CAPA AND SITUATION ANALYSES HAVE BEEN OPENED FOR THE INVESTIGATION OF CORRECTIVE ACTIONS LEADING TO AVOID RISKS OF ERRORS AND USER INJURY. THE ISSUE THAT THE HOOD GAS SPRINGS NEEDED REPLACEMENT WAS CONFIRMED BY THE FIELD SERVICE ENGINEER. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATED TO BARCODA LID FALL THROUGH CORRECTIVE AND PREVENTATIVE ACTIONS TO AVOID RISKS OF ERRORS AND USER INJURY. THIS COMPLAINT HAS BEEN INCLUDED IN THE CAPA FOR TRACEABILITY OF THE ISSUE. 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+¿ TLA THE BARCODA LID FELL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT HOOD GAS SPRINGS NEED REPLACEMENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ INOQULA+¿ TLA THE BARCODA LID FELL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED BY THE CUSTOMER THAT HOOD GAS SPRINGS NEED REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930849 BD KIESTRA¿ INOQULA+¿ TLA MICROBIAL SPECIMEN INOCULATION JTC BD KIESTRA LAB AUTOMATION 447213 00382904472139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown