BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD KIESTRA¿ INOQULA+¿

    MDR report key: 8279625 · Received January 25, 2019

    Report

    Report Number
    3010141591-2019-00101
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    January 1, 2019
    Report Date
    June 10, 2019
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THAT A LAB TECHNICIAN HAD SPRAINED HER WRIST BY CLOSING THE HOOD OF THE BARCODA. THE LABORATORY TECHNICIAN SOUGHT MEDICAL HELP FROM A PHYSICIAN AFTER THE INCIDENT AND WAS REPORTEDLY UNABLE TO WORK FOR SEVERAL DAYS DURING HER RECOVERY UNTIL SHE FINALLY RETURNED TO WORK. THE INCIDENT WAS CAUSED BY AN INCREASED FORCE TO OPEN AND CLOSE THE HOOD OF THE BARCODA. THE INCREASED FORCE WAS BECAUSE THE ORIGINAL WORN GAS SPRINGS WERE REPLACED BY GAS SPRINGS THAT WERE STRONGER. THESE GAS SPRINGS WERE REPLACED LATER BY THE CORRECT GAS SPRINGS WHAT SOLVED THE ISSUE. INVESTIGATION CONCLUSION: THE ORIGINAL GAS SPRINGS OF THE BARCODA HAD LOST THEIR STRENGTH AND COULD NOT HOLD THE BARCODA LID UP ANY MORE. THE FIELD SERVICE REPRESENTATIVE REPLACED THE GAS SPRINGS BUT DID NOT USE THE CORRECT TYPE OF GAS SPRING. THE INCORRECT GAS SPRINGS WERE MUCH STRONGER AND USERS STRUGGLED TO CLOSE THE BARCODA LID. ONE USER SPRAINED THEIR WRIST WHILE ATTEMPTING TO CLOSE THE LID. THE FIELD SERVICE REPRESENTATIVE WAS NOT AWARE THAT THE WRONG GAS SPRINGS WERE INSTALLED. AFTER NEW GAS SPRINGS WERE DELIVERED THE WRONG GAS SPRINGS WERE REPLACED AND INSTALLED BY THE PROPER GAS SPRINGS. TESTS WERE DONE WITH CLOSING AND LIFTING OF THE BARCODA HOOD DEMONSTRATING THE FUNCTIONALITY WAS AGAIN WITH EASE AND COMFORT. THE GAS SPRINGS HAVE BEEN CHECKED DURING PREVENTIVE MAINTENANCE. THE DEFECTIVE GAS SPRINGS WERE NOT AVAILABLE FOR ADDITIONAL INVESTIGATION. THE INCIDENT DID NOT IMPACT PATIENT TEST RESULTS. THE CUSTOMER WAS STILL ABLE TO PROCESS SAMPLES AND COULD MAINTAIN THE WORKFLOW. BECAUSE THE EMPLOYEE DID SEEK MEDICAL ASSISTANCE THE INCIDENT IS REPORTED TO THE CANADIAN HEALTH AUTHORITIES; MFR INITIAL REPORT. THE RISK OF THIS ISSUE WAS NOT FULLY ADDRESSED IN RISK MANAGEMENT DOCUMENT ¿HAZARD ANALYSIS FOR INOQULA¿, BALTRM-INOQULA-APH, REVISION 09. THIS HAZARD ANALYSIS HAS BEEN UPDATED BY A NEW REVISION 10 TO INCLUDE THE RISK OF THIS ISSUE. ROOT CAUSE DESCRIPTION: THE INCIDENT WAS CAUSED BY AN INCREASED FORCE TO OPEN AND CLOSE THE HOOD OF THE BARCODA BECAUSE THE ORIGINAL WORN GAS SPRINGS WERE REPLACED BY GAS SPRINGS THAT WERE STRONGER. RATIONALE: A CAPA INITIATION AND DETERMINATION WAS WRITTEN TO ADDRESS THE INCIDENT. ISSUE IS A SINGLE OCCURRENCE. COMPLIANT INVESTIGATION SHOWED THAT WRONG GAS SPRING WERE INSTALLED DURING A SERVICE ACTIVITY. WRONG GAS SPRINGS REQUIRED EXCESSIVE FORCE TO BE APPLIED DURING THE OPENING/CLOSING ACTIVITIES. THERE ARE NO RECORDS OF ADDITIONAL OCCURRENCE OF THIS ISSUE. GAS SPRINGS WERE CHANGED DUE TO THE WORN OUT OF ORIGINAL BARCODA HOOD GAS SPRINGS. NO CAPA REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE WORKING WITH A BD KIESTRA¿ INOQULA+¿, THE LAB TECHNICIAN FOUND THE INSTRUMENT LID WAS TIGHT AND DIFFICULT TO OPEN. IN ATTEMPTING TO OPEN THE INSTRUMENT LID, THE LAB TECHNICIAN SPRAINED THEIR WRIST. THE LAB TECHNICIAN SOUGHT MEDICAL ATTENTION FROM A PHYSICIAN FOLLOWING THE INCIDENT AND THEY WERE REPORTEDLY UNABLE TO WORK FOR MULTIPLE DAYS DURING THEIR RECOVERY BEFORE ULTIMATELY RETURNING TO WORK.

    Additional Manufacturer Narrative · 1

    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 WHILE WORKING WITH A BD KIESTRA¿ INOQULA+¿, THE LAB TECHNICIAN FOUND THE INSTRUMENT LID WAS TIGHT AND DIFFICULT TO OPEN. IN ATTEMPTING TO OPEN THE INSTRUMENT LID, THE LAB TECHNICIAN SPRAINED THEIR WRIST. THE LAB TECHNICIAN SOUGHT MEDICAL ATTENTION FROM A PHYSICIAN FOLLOWING THE INCIDENT AND THEY WERE REPORTEDLY UNABLE TO WORK FOR MULTIPLE DAYS DURING THEIR RECOVERY BEFORE ULTIMATELY RETURNING TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69838 BD KIESTRA¿ INOQULA+¿ MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention