BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA INOQULA

    MDR report key: 19069773 · Received April 9, 2024

    Report

    Report Number
    3010141591-2024-00005
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 4, 2024
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING THE BD KIESTRA INOQULA. ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE KIESTRA INOQULA BARCODA HOOD GAS SPRINGS WERE DAMAGED AND COULD NOT KEEP THE LID OPEN, CAUSING IT TO FALL AND CLOSE ON ITS OWN. DURING THE INVESTIGATION, THE SERVICE TECHNICAL SPECIALIST (STS) FOUND THAT THE ISSUE WAS DUE TO THE AGING OF THE GAS SPRINGS. THE STS REPLACED THE OLD GAS SPRINGS WITH A NEW SET AND TESTED THEIR FUNCTIONALITY, WHICH WAS FOUND TO BE NORMAL. 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 ANALYSES (SA) HAVE BEEN OPENED TO ADDRESS RISKS OF USER INJURY. AFTER THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) IT WAS CONCLUDED THAT THE INSTRUMENT HAS PASSED ALL INSPECTION TESTS AND WAS RELEASED IN A GOOD OPERATING CONDITION. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD KIESTRA INOQULA THE BARCODA PRINTER HOOD SPRING COULD NOT KEEP THE LID OPEN AND WOULD CLOSE ON ITS OWN. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284961 BD KIESTRA INOQULA DEVICE, MICROTITER DILUTING/DISPENSING JTC BD KIESTRA LAB AUTOMATION 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown