BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD CRITIKIT IN-LINE ICE TEMPERATURE INJECTATE KIT

    MDR report key: 1003826 · Received February 26, 2008

    Report

    Report Number
    8020616-2008-00011
    Event Type
    Other
    Date Received
    February 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 17, 2008
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. CONCLUSIONS: A ROOT CAUSE ANALYSIS COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT SENT FOR EVALUATION. A REVIEW OF THE MANUFACTURING PROCESS SHOWED THAT THE TRANSDUCER ASSEMBLY GOES THROUGH 100% VISUAL INSPECTION TO CHECK FOR CRACKED OR DAMAGED COMPONENTS DURING SUBASSEMBLY PROCESS. THE KIT ASSEMBLY ALSO GOES THROUGH 100% VISUAL INSPECTION TO CHECK FOR DAMAGED ASSEMBLY DURING THE KIT MANUFACTURING PROCESS AND SAMPLING VISUAL INSPECTION FOR DAMAGED COMPONENT DURING OUTGOING INSPECTION. THE ENGINEER CONCLUDES THAT A POSSIBLE CAUSE OF THIS EVENT COULD BE THE USER ACCIDENTALLY BENT THE SYRINGE DURING APPLICATION THAT CAUSED THE SYRINGE TO SNAP OFF. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE SYRINGE BROKE OFF FROM THE TUBING WHEN THE NURSE TRIED TO USE IT FOR THE SECOND INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD CRITIKIT IN-LINE ICE TEMPERATURE INJECTATE KIT PRESSURE MONITORING ACCESSORY DRS BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK