BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD KIESTRA INOQULA TLA

    MDR report key: 15033486 · Received July 15, 2022

    Report

    Report Number
    3010141591-2022-00011
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 16, 2022
    Report Date
    August 5, 2022
    Manufacturer
    KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472139
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDICAL USE. 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

    H 6. INVESTIGATION SUMMARY: THE FIELD SERVICE ENGINEER REPORTED THAT THE COVER OF THE BARCODA MODULE ON THE INSTRUMENT BD KIESTRA INOQULA TLA (MATERIAL #447213, SERIAL NUMBER (B)(6)) FELL DOWN ON LAB TECHNICIANS HAND CAUSING AN INJURY. ISSUE WAS CONFIRMED BY BD. THE FIELD SERVICE ENGINEER REPLACED THE TWO PNEUMATIC CYLINDERS ON THE BARCODA COVER TO ASSURE PROPER HOLD. THE INSTRUMENT WAS LEFT FULLY OPERATIONAL. BD HAS ISSUED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO INVESTIGATE THE ISSUE FURTHER. DESIGN HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD KIESTRA INOQULA TLA- BARCODA LID CAME DOWN ON TECH FINGER. TECHNICIAN REPORTS THAT A LAB TECH HAD THE BARCODA LID COME DOWN ON THEIR FINGER. THE TECH WENT TO THE EMERGENCY ROOM AND HAD X-RAYS. NO BROKEN BONE FOUND. NO BLOOD REPORTED, TECH HAS A SMALL BRUISE, A BAND-AID WAS GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD KIESTRA INOQULA TLA- BARCODA LID CAME DOWN ON TECH FINGER TECHNICIAN REPORTS THAT A LAB TECH HAD THE BARCODA LID COME DOWN ON THEIR FINGER. THE TECH WENT TO THE EMERGENCY ROOM AND HAD X-RAYS. NO BROKEN BONE FOUND. NO BLOOD REPORTED, TECH HAS A SMALL BRUISE, A BAND-AID WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111410 BD KIESTRA INOQULA TLA SEE H.10 JTC KIESTRA LAB AUTOMATION 447213 00382904472139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention