BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 12632714 · Received October 14, 2021

    Report

    Report Number
    1820334-2021-02329
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Report Date
    March 17, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. BAPTIST HEALTH IN THE UNITED STATES INFORMED COOK OF A GENERAL COMPLAINT ABOUT THE G2 DILATOR PRODUCT FROM WITHIN A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY TRAY/SET. AN RPN, DEVICE NAME, AND LOT NUMBER WERE NOT PROVIDED. HOWEVER, IT WAS REPORTED THAT THE G2 DILATOR IS NOT AS LUBRICATED, OR ¿SLIPPERY¿ WHEN WET AS THE PREVIOUS ITERATION. NO ADVERSE EFFECTS TO ANY PATIENTS WERE REPORTED. REVIEWS OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED, DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. THERE IS NO EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION, NOR SUGGESTS ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE ARE NONCONFORMING. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [C_T_PTIS_REV8] STATE THE FOLLOWING: "HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    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 THE G2 DILATOR INCLUDED IN THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WAS NOT AS LUBRICATED, OR SLIPPERY, WHEN WET AS THE PREVIOUS MODEL, MAKING ADVANCEMENT AND DEVICE USE DIFFICULT. NO ADVERSE EFFECTS WERE EXPERIENCED BY THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531563 UNKNOWN JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown