BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ INOQULA+¿ TLA

    MDR report key: 12715988 · Received October 28, 2021

    Report

    Report Number
    3010141591-2021-00002
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 30, 2021
    Report Date
    June 22, 2022
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6: "THE CUSTOMER REPORTED ON THE INSTRUMENT BD KIESTRA INOQULA WCA (MATERIAL # 447204 - SERIAL # (B)(6) THAT THE BARCODA SATO PRINTER LID WAS FALLING WHEN OPENED TO CHANGE THE PRINTER LABELS. THE AUTOMATION SERVICE ENGINEER ARRIVED ON SITE TO COMPLETE REPAIR ON THE BARCODA SATO PRINTER LID. THE AUTOMATION SERVICE ENGINEER COMPLETED THE REPAIR AS PER KLAFS0002 AND USED PART #446072 TO REPLACE THE GAS SHOCKS ON THE BARCODA PRINTER LID AND FOUND NO OTHER ISSUES. THE INSTRUMENT WAS TESTED WITHOUT ERRORS AND WAS RETURNED TO THE CUSTOMER FOR NORMAL USE. CAPA# 5284707 AND SITUATION ANALYSES IDS-22-4486 HAVE BEEN OPENED FOR THE INVESTIGATION OF THE POTENTIAL GAP IN IMPLEMENTATION OF CORRECTIVE ACTIONS LEADING TO INCREASED RISKS OF USER INJURY AFTER COMPLAINTS WERE RECEIVED DESCRIBING ISSUES WITH DROPPING BARCODA HOOD. THIS COMPLAINT HAS BEEN INCLUDED IN CAPA# 5284707 FOR TRACEABILITY OF THE ISSUE. THE ISSUE THAT THE BARCODA SATO PRINTER LID WAS FALLING WHEN OPENED WAS CONFIRMED BY THE AUTOMATION SERVICE ENGINEER. ROOT CAUSE DESCRIPTION: WORN GAS SHOCKS ON THE BARCODA SATO PRINTER. A REVIEW OF RISK MANAGEMENT DOCUMENTATION INDICATES THAT THE POTENTIAL RISK OF THE REPORTED FAILURE MODE WAS APPROPRIATELY ASSESSED AS S3 VIA BALTRM-INOQULA-APH - REV 14, ID 2.22".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD KIESTRA¿ INOQULA+¿ TLA EXPERIENCED A BARCODA LID THAT KEPT FALLING OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED BARCODA SATO PRINTER LID IS FALLING WHEN OPENED TO CHANGE THE PRINTER LABELS.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD KIESTRA¿ INOQULA+¿ TLA EXPERIENCED A BARCODA LID THAT KEPT FALLING OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED BARCODA SATO PRINTER LID IS FALLING WHEN OPENED TO CHANGE THE PRINTER LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612936 BD KIESTRA¿ INOQULA+¿ TLA MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown