BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOH TUBE TRACHEOSTOMY AND TUBE CUFF

    MDR report key: 8837409 · Received July 29, 2019

    Report

    Report Number
    1820334-2019-01830
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Report Date
    December 6, 2019
    Manufacturer
    COOK INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION - EVALUATION: A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED, AS THE LOT INFORMATION WAS NOT PROVIDED BY THE FACILITY. A GLOBAL SALES SHIPMENT REPORT WAS CONDUCTED FROM 01JAN2016 THROUGH 09JUL2019, AND IT WAS REVEALED THAT THE FACILITY BOUGHT 32 LOTS FOR THREE RPNS. IT SHOULD BE NOTED THAT THERE HAVE BEEN NO COMPLAINTS REPORTED FOR THESE LOT NUMBERS. THERE IS NO EVIDENCE TO SUGGEST THAT NONCONFORMING PRODUCT FROM THE AFFECTED LOTS EXISTS IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INTENDED USE: ¿SUBSEQUENT DILATION OF THE TRACT AND TRACHEAL ENTRANCE SITE PERMITS PASSAGE OF THE EMERGENCY AIRWAY CATHETER.¿ WARNINGS: ¿¿ ARE NOT SPECIFICALLY DESIGNED FOR PEDIATRIC APPLICATIONS.¿ ¿CONSIDERATIONS SHOULD BE GIVEN TO THE FOLLOWING MEDICAL AND ANATOMIC CONDITIONS: DISTORTED ANATOMY, SUBCUTANEOUS ABSCESS, HEMATOMA, POST-OPERATIVE SCARRING/RADIATION, AND COAGULOPATHIES OR SYSTEMIC THROMBOLYTIC THERAPY.¿ INSTRUCTIONS FOR USE: ¿¿ MAKE A VERTICAL INCISION IN THE MIDLINE. NOTE: ENSURE THAT THE INCISION IS SUFFICIENTLY LARGE TO ALLOW PASSAGE OF THE DILATOR AND AIRWAY CATHETER.¿ ¿ADVANCE THE HANDLED DILATOR, TAPERED END FIRST, INTO THE CONNECTOR END OF THE AIRWAY CATHETER UNTIL THE HANDLE STOPS AGAINST THE CONNECTOR.¿ ¿ADVANCE THE AIRWAY CATHETER/DILATOR ASSEMBLY OVER THE WIRE GUIDE UNTIL THE PROXIMAL STIFF END OF THE WIRE GUIDE IS COMPLETELY THROUGH AND VISIBLE AT THE HANDLE END OF THE DILATOR.¿ ¿¿ CONTINUE TO ADVANCE THE AIRWAY CATHETER/DILATOR ASSEMBLY OVER THE WIRE GUIDE WITH A RECIPROCATING MOTION COMPLETELY INTO THE TRACHEA.¿ 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, THE CAUSE COULD BE CONTRIBUTED TO A COMPONENT FAILURE AND AN UNINTENDED USE ERROR. IF THE IFU WAS NOT PROPERLY FOLLOWED OR IF THE PATIENT¿S ANATOMY WAS TORTUOUS, THIS COULD HAVE CONTRIBUTED TO DIFFICULTY OF DILATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    REPORTED AS MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET, UNKNOWN RPN. COMMON NAME & PRODUCT CODE: UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. ADDITIONAL PRO-CODE, BWC. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. DID NOT DILATE TISSUE. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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 CATHETER OF A MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET DID NOT DILATE THE TISSUE DURING A WIRE-GUIDED CRICOTHYROTOMY. THE WIRE WENT IN BUT THE CATHETER DID NOT DILATE THE TISSUE, RESULTING IN A FAILED ATTEMPT." IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. THE CUSTOMER REPORTED THAT THIS OCCURRED THREE TIMES AND IT IS NOT KNOWN IF IT WAS DURING THE SAME PROCEDURE OR SEPARATE PROCEDURES. REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE EVENT AND THE PATIENT WERE SENT TO THE CUSTOMER BUT HAVE NOT BEEN ANSWERED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632930 JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1