BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 12059524 · Received June 24, 2021

    Report

    Report Number
    1820334-2021-01593
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Report Date
    April 12, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: (B)(6) HOSPITAL (CANADA) INFORMED COOK OF AN ISSUE WITH A C-PTIS-100-HC-G-EU (BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET) FROM AN UNKNOWN LOT. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO ADVANCE THE CIAGLIA BLUE RHINO DILATOR. THE DILATOR MADE AN S-BEND AS A RESULT OF THE FORCE EXERTED ON THE HORN OF THE DEVICE. THE GUIDEWIRE WAS ALSO NOTED TO HAVE BENT. A MODIFIED APPROACH USING TWO HANDS IN ORDER TO STABILIZE THE DEVICE DURING INSERTION WAS UTILIZED. THE PATIENT(S) WAS HOSPITALIZED, BUT NOT AS A RESULT OF THIS INCIDENT. NO ADVERSE EFFECTS HAVE BEEN REPORTED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THERE ARE CONTROLS IN PLACE TO ADDRESS THE REPORTED FAILURE MODE. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED BY THE CUSTOMER. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS ABLE TO IDENTIFY TWO POSSIBLE COMPLAINT LOT NUMBERS: 13897459 AND 13952692. BOTH DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELATED NONCONFORMANCES WERE NOTED. A DATABASE SEARCH DID NOT FIND COMPLAINTS FROM THE FIELD FOR EITHER LOT NUMBER. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: "HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, LACK OF PRODUCT RETURN, AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK 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 THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    CUSTOMER (PERSON): (B)(6). OCCUPATION: BUYER, PURCHASING DEPARTMENT. PMA/510(K) #: K193133. 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 BLUE RHINO DILATORS INCLUDED IN TWO-THREE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SETS BENT AS THEY WERE NOT STIFF ENOUGH TO PENETRATE THE PATIENT(S) DURING INSERTION FOR PERCUTANEOUS TRACHEOSTOMY. THE DEVICES WERE PLACED IN THE TRACHEA(S). FOR ALL DEVICES, THE DILATORS MADE AN "S-BEND" AS A RESULT OF FORCE EXERTED ON THE HORN PORTIONS. THIS HAS ALSO RESULTED IN BENDING OF THE WIRE GUIDES. THE BLUE RHINO DILATORS WERE DESCRIBED AS "MORE FLIMSY, SOFT, AND UNSTABLE" THAN A COMPARABLE DEVICE. THE PHYSICIAN WAS STATED TO BE "HIGHLY EXPERIENCED IN PERFORMING PERCUTANEOUS TRACHEOSTOMIES". SINCE USING THIS DEVICE, THE PHYSICIAN HAS HAD TO MODIFY THEIR APPROACH BY USING THE BLUE RHINO DILATOR HORN TO STABILIZE IT UPON INSERTION. THEY NOW USE A "2-HANDED APPROACH" TO "HELP STABILIZE AND GUIDE THE UNSTABLE BLUE RHINO DILATOR HORN WITH 2 HANDS AS OPPOSED TO ONE". THE PATIENT(S) WAS HOSPITALIZED, BUT NOT AS A RESULT OF THIS INCIDENT. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955411 BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown