BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 7397980 · Received April 4, 2018

    Report

    Report Number
    1820334-2018-00861
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 22, 2018
    Manufacturer
    COOK INC
    Product Code
    CBI
    UDI-DI
    00827002441095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND VISUAL INSPECTION OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE UNOPENED C-AEBS ENDOBRONCHIAL BLOCKER SET WAS RETURNED. A SMALL, BROWN, UNIDENTIFIED PIECE OF FOREIGN MATTER WAS PRESENT IN THE SEALED PACKAGE. FOREIGN MATTER HAS BEEN CONFIRMED ADDITIONALLY, A DOCUMENT BASED INVESTIGATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 7853565 REVEALED NO NOTABLE NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A SEARCH OF OUR COMPLAINT MANAGEMENT SYSTEM REVEALED THIS TO BE THE ONLY REPORTED COMPLAINT FROM LOT NUMBER 7853565. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. C_T_AEBS_REV.3 [ARNDT ENDOBRONCHIAL BLOCKER SET] STATES: "HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." IT IS REASONABLE TO SUGGEST THAT FOREIGN MATTER WAS INTRODUCED DURING THE MANUFACTURING PROCESS BEFORE THE DEVICE'S PACKAGE WAS SEALED. THE CAUSE OF THIS IS MANUFACTURING RELATED. THIS FAILURE MODE IS BEING ESCALATED PER INTERNAL PROCESSES. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE PROPER PERSONNEL ABOUT THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). 510K -K160542. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED PRIOR TO PATIENT CONTACT THE ARNDT ENDOBRONCHIAL BLOCKER SET WAS NOTED TO HAVE A FOREIGN OBJECT IN THE STERILE PACKAGING. THE PRODUCT AND PACKAGING HAS BEEN RECEIVED FOR EVALUATION AND INVESTIGATION; HOWEVER, THE INVESTIGATION IS STILL IN PROGRESS AT THE TIME OF THIS REPORT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240327 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC NA 00827002441095

    Patients

    Seq Age Sex Outcome Treatment
    1