BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ INOQULA+¿

    MDR report key: 14635357 · Received June 8, 2022

    Report

    Report Number
    3010141591-2022-00008
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 16, 2022
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    H6: INVESTIGATION SUMMARY THE CUSTOMER CARE ENGINEER REPORTED ON THE INSTRUMENT BD KIESTRA INOQULA WCA (MATERIAL # 447204 - SERIAL # (B)(6)) THAT THE HOOD OF THE BARCODA NO LONGER HOLDS. THE CUSTOMER CARE ENGINEER REPLACED THE JACKS THAT HOLD THE COVER ABOVE THE PRINTER. CORRECTIVE AND PREVENTIVE ACTION (CAPA) 5284707 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 OF THE BARCODA NO LONGER HOLDS WAS CONFIRMED BY THE CUSTOMER CARE ENGINEER. THIS COMPLAINT HAS BEEN INCLUDED IN CAPA 5284707 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. 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 LID WAS NOT HELD UP. THERE WAS NO CUSTOMER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: HOOD CYLINDER NO LONGER HOLD. COMMENTS: SITUATION ON ARRIVAL/CURRENT SITUATION: FUNCTIONAL BARCODA / FUNCTIONAL BARCODA. ACTION TAKEN ON THE ORIGINAL ISSUE: REPLACEMENT OF THE JACKS THAT HOLD THE COVER ABOVE THE PRINTER. SOFTWARE VERSION: BARCODA V26.0.1. CAUSE OF THE PROBLEM: THE HOOD OF THE BARCODA NO LONGER HOLDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ INOQULA+¿ THE LID WAS NOT HELD UP. THERE WAS NO CUSTOMER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "HOOD CYLINDER NO LONGER HOLD. COMMENTS: 1. SITUATION ON ARRIVAL/CURRENT SITUATION: FUNCTIONAL BARCODA / FUNCTIONAL BARCODA. 2. ACTION TAKEN ON THE ORIGINAL ISSUE: REPLACEMENT OF THE JACKS THAT HOLD THE COVER ABOVE THE PRINTER. 3. SOFTWARE VERSION: BARCODA V26.0.1 4. CAUSE OF THE PROBLEM: THE HOOD OF THE BARCODA NO LONGER HOLDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18419 BD KIESTRA¿ INOQULA+¿ MICROTITER DILUTING/DISPENSING DEVICE JTC BD KIESTRA LAB AUTOMATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown