BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD KIESTRA¿ INOQULA+¿ TLA

    MDR report key: 8771738 · Received July 9, 2019

    Report

    Report Number
    3010141591-2019-00104
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 11, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INFORMED THE FIELD SERVICE REPRESENTATIVE THAT AN OPERATOR WAS INJURED DUE TO THE BARCODA-1 HOOD CLOSING ON THE OPERATORS HAND. MEDICAL CARE WAS PROVIDED, AND THE OPERATOR WAS ON SICK LEAVE FOR APPROXIMATELY 1 WEEK. THE GAS SPRINGS OF THE HOOD WERE WORN RESULTING IN A REDUCED FORCE HOLDING THE HOOD IN THE OPENED POSITION. THE GAS SPRINGS FOR THE HOOD OF THE BARCODA-1 HAVE BEEN REPLACED TO SOLVED THE PROBLEM. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE. THE BARCODA HOOD WAS NOT HELD IN THE OPENED POSITION DUE TO WORN OUT GAS SPRINGS OF THE HOOD THAT REDUCED THE FORCE TO HOLD THE HOOD OPEN. DUE TO THIS THE HOOD WAS FALLEN ON AN OPERATORS HAND CAUSING A PINCHED FINGERTIP WITH A BLEEDING CUT. THE WOUND WAS CLEANED, DISINFECTED, AND THEN DRESSED. X-RAYS WERE TAKEN SHOWING A BRIGHT LINE VISIBLE BUT SEEN AS NORMAL VARIATION. NO SINEWS OR BONES WERE HARMED. ALTHOUGH THE GAS SPRINGS WERE CAPABLE OF HOLDING THE HOOD IN THE FULLY OPENED POSITION, THE FORCE WAS NOT STRONG ENOUGH TO HOLD THE HOOD WHEN IT WAS NOT FULLY OPENED. THE HOOD IS NOT DESIGNED AS ¿SOFT-CLOSE¿ BUT ONLY TO HOLD THE HOOD OPEN. THE GAS SPRINGS ARE ABLE TO HOLD THE HOOD IN ITS OPEN POSITION OR ALMOST OPEN POSITION HOWEVER IT IS NOT DEFINED HOW MUCH THE HOOD NEEDS TO BE OPENED TO KEEP IT OPEN BY THE GAS SPRINGS. TESTING BY THE FIELD SERVICE REPRESENTATIVE SHOWED THAT THE WORN GAS SPRINGS WERE STILL ABLE TO HOLD THE HOOD OPEN IN THE FULLY OPENED POSITION. IT IS ASSUMED THAT THE OPERATOR HAD NOT FULLY OPENED THE HOOD AND DUE TO THE REDUCED FORCE OF THE GAS SPRINGS THE HOOD DID FALL DOWN. AS A WORK-AROUND THE CUSTOMER COULD CONTINUE WORKING BY FULLY OPENING THE HOOD. IT HAS BEEN CHECKED AND CONFIRMED THAT THE GAS SPRINGS WERE MOUNTED CORRECTLY. THE GAS SPRINGS WERE REPLACED BY NEW ONES. THE ISSUE OF THIS COMPLAINT IS WITHIN THE SCOPE OF AN EXISTING CAPA; PR 931335 - INOQULA - BARCODA HOOD DROPPED ON USERS HAND (MINOR INJURY). THE CAPA OWNER HAS BEEN INFORMED ABOUT THIS COMPLAINT AND INCLUDED THIS COMPLAINT IN THE SCOPE OF THE CAPA. THE ISSUE HAS BEEN REPORTED TO THE FDA (MFR REPORT NUMBER: 3010141591-2019-00104) AND BFARM, REF. (B)(4).) ROOT CAUSE DESCRIPTION: REDUCED FORCE OF THE GAS SPRINGS IN COMBINATION WITH A PARTIALLY OPENED HOOD CAUSED THE HOOD TO CLOSE. A CAPA EXISTS FOR THE SAME ISSUE, PR 931335 - INOQULA - BARCODA HOOD DROPPED ON USERS HAND (MINOR INJURY). THE ISSUE OF COMPLAINT PR 1016913 IS INCLUDED IN THE SCOPE OF THIS CAPA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LID OF BD KIESTRA¿ INOQULA+¿ TLA BARCODA-1 WAS NOT HELD IN POSITION BY GAS SPRINGS. THE ROOT CAUSE WAS THAT THE GAS SPRING LOST GAS PRESSURE. ADDITIONALLY, THE CUSTOMER MAY NOT HAVE PLACED THE LID IN THE HIGHEST POSITION. THE USERS FINGERTIP WAS PINCHED WHICH RESULTED IN A CUT AND THERE WERE ALSO SIGNS OF BRUISING. THE USER WAS TREATED BY A MEDICAL PROFESSIONAL; THE WOUND WAS CLEANED, DISINFECTED, AND DRESSED. THERE WERE NO SINEWS OR BONES HARMED.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: (B)(6). 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 LID OF BD KIESTRA¿ INOQULA+¿ TLA BARCODA-1 WAS NOT HELD IN POSITION BY GAS SPRINGS. THE ROOT CAUSE WAS THAT THE GAS SPRING LOST GAS PRESSURE. ADDITIONALLY, THE CUSTOMER MAY NOT HAVE PLACED THE LID IN THE HIGHEST POSITION. THE USERS FINGERTIP WAS PINCHED WHICH RESULTED IN A CUT AND THERE WERE ALSO SIGNS OF BRUISING. THE USER WAS TREATED BY A MEDICAL PROFESSIONAL; THE WOUND WAS CLEANED, DISINFECTED, AND DRESSED. THERE WERE NO SINEWS OR BONES HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566737 BD KIESTRA¿ INOQULA+¿ TLA MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S