BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 8153517 · Received December 11, 2018

    Report

    Report Number
    1820334-2018-03462
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Report Date
    January 24, 2019
    Manufacturer
    COOK INC
    Product Code
    CBI
    UDI-DI
    00827002441118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION HAS PREVIOUSLY BEEN REPORTED, IS UNKNOWN OR IS UNAVAILABLE. DEVICE EVALUATION: THE REPORTED UNUSED SEALED COMPLAINT DEVICE WAS RETURNED TO COOK INC. FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE REPORT OF FOREIGN MATTER AS A BROWN FILAMENT WAS IDENTIFIED INSIDE THE PACKAGE NEAR THE BLUE EXTENSION TUBE HUB. INVESTIGATION: A DOCUMENT-BASED INVESTIGATION REVIEWED THE FOLLOWING: INSTRUCTIONS FOR USE, QUALITY CONTROL, SPECIFICATIONS, COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS AND DEVICE HISTORY RECORD. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: ADDITIONAL INVESTIGATION ACTIVITIES RELATED TO QUALITY CONTROL WERE PERFORMED DURING THE PRODUCTIONS OF THIS LOT. AS A RESULT OF THIS ACTIVITY, NEW GOWNING PROCEDURES HAVE BEEN IMPLEMENTS TO PREVENT THIS FAILURE. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. 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.

    Description of Event or Problem · 0

    SEE H10.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: 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

    IT WAS REPORTED THAT A HAIR WAS IDENTIFIED IN THE STERILE PACKAGING OF A ARNDT ENDOBRONCHIAL BLOCKER SET, PRIOR TO USE ON THE PATIENT. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989250 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC NA 7519768 00827002441118

    Patients

    Seq Age Sex Outcome Treatment
    1