BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ INOQULA+¿

    MDR report key: 13934915 · Received March 29, 2022

    Report

    Report Number
    3010141591-2022-00005
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    January 21, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: "THE FIELD SERVICE ENGINEER REPORTED ON THE BD KIESTRA INOQULA (MATERIAL # 447202 - SERIAL # (B)(6). ) THAT THE COVER ON THE PRINTER FALLS OFF SPORADICALLY. THE DAMPERS NEED TO BE REPLACED. THE PRODUCT TECHNICAL SPECIALIST REPLACED THE DAMPERS (SPARE PART 5000-555-10). THE DAMPERS WERE DEFECTIVE, AND THE LID LOWERED AUTOMATICALLY. CORRECTIVE AND PREVENTIVE ACTION (CAPA) AND SITUATION ANALYSIS (SA) HAVE BEEN OPENED FOR THE INVESTIGATION OF CORRECTIVE ACTIONS LEADING TO AVOID RISKS OF ERRORS AND USER INJURY. THE ISSUE THAT THE COVER ON THE PRINTER FALLS OFF SPORADICALLY WAS CONFIRMED BY THE FIELD SERVICE ENGINEER. 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 THE PRINTER LID ON BD KIESTRA¿ INOQULA+¿ WAS FALLING. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE COVER ON THE PRINTER FALLS OFF SPORADICALLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THE PRINTER LID ON BD KIESTRA¿ INOQULA+¿ WAS FALLING. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE COVER ON THE PRINTER FALLS OFF SPORADICALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20325 BD KIESTRA¿ INOQULA+¿ MICROTITER DILUTING/DISPENSING DEVICE JTC BD KIESTRA LAB AUTOMATION 447202 NA 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown