JOH TUBE TRACHEOSTOMY AND TUBE CUFF
Report
- Report Number
- 1820334-2019-00023
- Event Type
- Injury
- Date Received
- January 10, 2019
- Date of Event
- December 6, 2018
- Report Date
- April 30, 2019
- Manufacturer
- COOK INC
- Product Code
- JOH
- PMA / PMN Number
- K133597
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS PREVIOUSLY SUBMITTED, UNKNOWN, OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A PICTURE OF THE DEVICE WAS PROVIDED AND CLEARLY SHOWED THAT THE RIDGE SEPARATED FROM THE OUTER CANNULA ON THE USED DEVICE. SINCE THE DEVICE WAS NOT RETURNED, IT CANNOT BE VERIFIED TO HAVE BEEN MANUFACTURED OUT OF SPECIFICATION. IT WAS FOUND DURING THE INVESTIGATION THAT THE AFFECTED COMPONENT WAS SUPPLIED TO COOK FROM AN EXTERNAL SUPPLIER, AND IT WAS REQUESTED OF THE SUPPLIER TO INVESTIGATE THIS OCCURRENCE. MULTIPLE ATTEMPTS TO OBTAIN THE RESULTS OF THE SUPPLIER INVESTIGATION WERE UNSUCCESSFUL. SHOULD THE SUPPLIER INVESTIGATION BE PROVIDED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT THERE ARE SUFFICIENT CONTROLS IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED, AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ONLY PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS TRACHEOSTOMY TECHNIQUES SHOULD USE THIS DEVICE. EXERCISE CARE TO ENSURE THAT THE COMPONENTS USED IN EACH STEP ARE PROPERLY POSITIONED WITHIN THE TRACHEA. IMPROPER PLACEMENT OF THE COMPONENTS MAY LEAD TO POTENTIALLY LIFE-THREATENING INJURY. PRECAUTIONS: THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS TRACHEOTOMY TECHNIQUES. STANDARD TECHNIQUES FOR PERCUTANEOUS PLACEMENT OF TRACHEOSTOMY TUBES SHOULD BE EMPLOYED. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND 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.
IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 THAT THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AS REPORTED ON (B)(6) 2019, THE PATIENT IS CURRENTLY DOING WELL AND IS OUT OF THE ICU.
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
BRAND NAME: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH SHILEY. PATIENT CODE: NO CODE AVAILABLE - REPLACEMENT DEVICE REQUIRED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THE FLANGE (LATER CLARIFIED TO BE THE OUTER CANNULA) OF A SHILEY TUBE BROKE WHILE IN SITU. THIS SHILEY TUBE WAS A COMPONENT IN A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET. AN IMAGE SENT BY THE CUSTOMER SHOWS THE LOCATION OF THE BREAK TO BE ON THE OUTER CANNULA'S FLANGE WHERE THE INNER CANNULA CONNECTS VIA CLIPS. TO DATE, ADDITIONAL PATIENT, EVENT AND DEVICE INFORMATION HAVE BEEN REQUEST BUT NOT YET PROVIDED. A S REPORTED, THIS DEVICE ISSUE WAS CAUSED BY THE PATIENT AND A REPLACEMENT TRACHEOSTOMY TUBE WAS REQUIRED SOONER THAN CLINICALLY RECOMMENDED. THE PATIENT WAS BEING WEANED FROM VENTILATION AND WAS BETWEEN CPAP AND VENTILATION.
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(4) 2019 CONFIRMED THAT THE DEVICE WAS PART OF THE COOK SET BUT THE LOT NUMBER WAS UNKNOWN. THE REPLACEMENT DEVICE WAS PLACED IN THE SAME LOCATION. FURTHERMORE, IT WAS REPORTED THAT THE FAILURE MODE WAS REPLICATED ON A DIFFERENT TUBE WHICH WAS ALSO FROM A COOK SET. THE LOT NUMBER OF THIS UNUSED DEVICE WAS ALSO UNKNOWN. THIS EVENT IS REPORTED IN MDR 1820334-2019-00327.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30886 | JOH TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | COOK INC | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |