BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ INOQULA+¿ TLA

    MDR report key: 19484643 · Received June 7, 2024

    Report

    Report Number
    3010141591-2024-00006
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 9, 2024
    Report Date
    August 7, 2024
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472139
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. ADDITIONAL PHONE #: (B)(6). H3. 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

    INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING THE BD KIESTRA INOQULA TLA. ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE FA HOOD GAS SPRINGS NEEDED REPLACEMENT. DURING THE INVESTIGATION, THE AUTOMATION SERVICE ENGINEER (ASE) DISCOVERED THAT THE HOOD WOULD DESCEND ON ITS OWN. THE ASE REPLACED THE GAS SPRINGS. FOLLOWING THE REPLACEMENT, THE INSTRUMENT WAS RETURNED TO THE CUSTOMER AND FUNCTIONED AS EXPECTED. FOLLOWING THIS ACTION, NO FURTHER ISSUES WERE ENCOUNTERED. BASED ON THE INVESTIGATION, THIS CASE HAS BEEN ASSESSED AS CONFIRMED FOR A BD QUALITY ISSUE. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) AND SITUATION ANALYSIS (SA) HAVE BEEN OPENED FOR THE INVESTIGATION TO AVOID RISKS OF USER INJURY AFTER COMPLAINTS WERE RECEIVED DESCRIBING ISSUES WITH THE BARCODA HOOD DROPPING. THIS COMPLAINT HAS BEEN INCLUDED IN THE CAPA FOR TRACEABILITY OF THE ISSUE. A 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 DURING USE WITH THE BD KIESTRA¿ INOQULA+¿ TLA, THE BARCODA HOOD FELL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD KIESTRA¿ INOQULA+¿ TLA, THE BARCODA HOOD FELL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258497 BD KIESTRA¿ INOQULA+¿ TLA MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION 00382904472139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown