BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD KIESTRA INOQULA+

    MDR report key: 10733684 · Received October 26, 2020

    Report

    Report Number
    1119779-2020-00774
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 30, 2020
    Report Date
    February 1, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE TABLE TOP HOOD ABOVE THE SATO PRINTER OF THE INOQULA (SERIAL NUMBER (B)(6)) WOULD NOT STAY UP. ONE LAB TECHNICIAN WAS INJURED DUE TO THE COVER SLAMMING DOWN ON HER FINGERS. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND FOUND THAT THE GAS SPRINGS ON THE HOOD WERE WORN OUT. THIS CONFIRMED THE COMPLAINT. THE FSE REPLACED THE GAS SPRINGS AND SPRING CLIPS. THIS SOLVED THE ISSUE AND THE SYSTEM WAS FUNCTIONING CORRECTLY AGAIN. CAPA (B)(4) WAS OPENED ON 30 APRIL 2019 FOR A SIMILAR ISSUE WITH A FALLING HOOD DUE TO WORN GAS SPRINGS. CORRECTION AT CUSTOMER LOCATION HAS TAKEN PLACE, BY REPLACING THE GAS SPRINGS. FURTHER CORRECTIVE ACTIONS WILL FOLLOW FROM THE CAPA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE CHANGING THE BARCODE LABELS ON THE BD KIESTRA¿ INOQULA+¿, THE PRINTER COVER SLAMMED DOWN ON THE TECHNICIAN¿S THREE (3) MIDDLE FINGERS. THE TECHNICIAN REPORTED TO NURSE/OCCUPATIONAL FOR EVALUATION. WHEREIN IT WAS REPORTED THERE WAS NO EVIDENCE OF BROKEN BONES, BUT BRUISING WAS NOTED. NO PAIN MEDICATION WAS ADMINISTERED, NO ADDITIONAL PATIENT INFORMATION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CHANGING THE BARCODE LABELS ON THE BD KIESTRA¿ INOQULA+¿, THE PRINTER COVER SLAMMED DOWN ON THE TECHNICIAN¿S THREE (3) MIDDLE FINGERS. THE TECHNICIAN REPORTED TO NURSE/OCCUPATIONAL FOR EVALUATION. WHEREIN IT WAS REPORTED THERE WAS NO EVIDENCE OF BROKEN BONES, BUT BRUISING WAS NOTED. NO PAIN MEDICATION WAS ADMINISTERED, NO ADDITIONAL PATIENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200528 BD KIESTRA INOQULA+ MICROBIAL SPECIMEN INOCULATION JTC BECTON, DICKINSON & CO. (SPARKS) 447202 NA 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention