BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA INOQULA

    MDR report key: 12822055 · Received November 16, 2021

    Report

    Report Number
    1119779-2021-01829
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 20, 2021
    Report Date
    June 22, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    EXEMPT
    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

    MEDICAL DEVICE EXPIRATION DATE: NA. 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

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 FIELD SERVICE ENGINEER REPORTED ON THE BD KIESTRA INOQULA (MATERIAL # 447202 - SERIAL # (B)(6), WHILE BEING ONSITE FOR A PRINTER VACUUM ERROR ON THE BARCODA PRINTER, NOTICED THAT THE GAS SPRING ON THE HOOD COVER OF THE BARCODA PRINTER DID NOT HOLD THE HOOD COVER WHEN OPENED. THE FIELD SERVICE ENGINEER REPLACED THE GAS SPRINGS AS PER KLAFS0002 INOQULA SERVICE MANUEL REV.12 AND USED PART # 5000-555-19: BARCODA SMALL TOP COVER GAS SPRING, WHICH PART WAS ORDERED FROM SHR 655, 446072 - GAS SPRING 08-19 80 205 100N AND CLEVIS. THE NEW GAS SPRINGS WERE TESTED WITHOUT ERRORS. THE INOQULA STAND-ALONE WAS RETURNED TO THE CUSTOMER FOR NORMAL USE. THE INOQULA STAND-ALONE IS FUNCTIONING PROPERLY AND FULLY OPERATIONAL. CAPA 5284707 HAS BEEN INITIATED 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 GAS SPRING ON THE HOOD COVER OF THE BARCODA PRINTER DID NOT HOLD THE HOOD COVER WHEN OPENED WAS CONFIRMED BY THE FIELD SERVICE ENGINEER. THIS COMPLAINT HAS BEEN INCLUDED IN THE 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. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPRINGS ON THE BARCODA PRINTER WITH A BD KIESTRA INOQULA FAILED TO HOLD UP THE LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CURRENT GAS SPRINGS FOR BARCODA PRINTER HOOD COVER FAILED TO HOLD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPRINGS ON THE BARCODA PRINTER WITH A BD (B)(6) FAILED TO HOLD UP THE LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CURRENT GAS SPRINGS FOR BARCODA PRINTER HOOD COVER FAILED TO HOLD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPRINGS ON THE BARCODA PRINTER WITH A BD KIESTRA INOQULA FAILED TO HOLD UP THE LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CURRENT GAS SPRINGS FOR BARCODA PRINTER HOOD COVER FAILED TO HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718170 BD KIESTRA INOQULA DEVICE, MICROTITER DILUTING/DISPENSING JTC BECTON, DICKINSON & CO. (SPARKS) 447202 NA 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown