JOH TUBE TRACHEOSTOMY AND TUBE CUFF
Report
- Report Number
- 1820334-2022-00599
- Event Type
- Injury
- Date Received
- April 18, 2022
- Date of Event
- September 14, 2021
- Report Date
- July 20, 2023
- Manufacturer
- COOK INC
- Product Code
- JOH
- PMA / PMN Number
- K133597
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLUE RHINO SET, NO RPN OR LOT PROVIDED. INITIAL REPORTER: DISTRIBUTION MANAGER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: ON 02NOV2021, IT WAS REPORTED BY KEVIN CACI OF MONMOUTH MEDICAL CENTERS CAMPUS (UNITED STATES) THAT ON 14SEP2021 THE 14FR PUNCH DILATOR IN COOK BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET (RPN: UNKNOWN; LOT#: UNKNOWN) BENT. THE DEVICE WAS REQUIRED FOR A PERCUTANEOUS TRACHEOSTOMY PROCEDURE IN THE CRITICAL CARE UNIT (CCU). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THE PUNCH DILATOR BENT WHICH CAUSED THE WIRE GUIDE TO ALSO BEND. THE DEVICE WAS IN PLACE FOR APPROXIMATELY 3 HOURS; HOWEVER, DUE TO THE EXPERIENCED DIFFICULTY, AN OPEN TRACHEOSTOMY PROCEDURE WAS THEN PERFORMED. NO OTHER ADVERSE EVENTS WERE REPORTED DUE TO THIS OCCURRENCE. A REVIEW OF THE 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. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS NO EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION, OR THAT THERE ARE NON-CONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_PTISGI2_REV4] ¿CIAGLIA BLUE RHINO G2 ADVANCED PERCUTANEOUS TRACHEOSTOMY INTRODUCER,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: ¿BRONCHOSCOPIC GUIDANCE IS STRONGLY RECOMMENDED DURING PLACEMENT OF THIS DEVICE TO REDUCE THE LIKELIHOOD OF PARATRACHEAL INSERTION AND TO DETERMINE THE INTRATRACHEAL POSITION OF THE NEEDLE, WIRE GUIDE, DILATORS, AND TRACHEOSTOMY TUBE. ¿ ¿AN ULTRASOUND EVALUATION OF THE PATIENT¿S NECK PRIOR TO THE PROCEDURE MAY AID IN IDENTIFICATION OF ANATOMICAL VARIANCES.¿ ¿THE GENEROUS LUBRICATION OF THE LOADING DILATOR SURFACE WILL ENHANCE FIT AND PLACEMENT OF THE TRACHEOSTOMY TUBE.¿ INSTRUCTIONS FOR USE: PATIENT PREPARATION ¿2. PLACE THE PATIENT IN THE TRACHEOSTOMY POSITION. POSITION A PILLOW UNDER THE SHOULDERS TO PERMIT FULL EXTENSION OF HEAD AND NECK. THE HEAD OF THE PATIENT'S BED MAT BE ELEVATED TO 30-40 DEGREES AT THE PHYSICIAN'S DISCRETION. 6. GENEROUSLY LUBRICATE THE SURFACE OF THE APPROPRIATELY SIZED LOADING DILATOR AND LOAD THE TRACHEOSTOMY TUBE ONTO THE THE DILATOR, ENSURE THAT THE TRACHEOSTOMY TUBE'S TIP FITS SNUGLY ON THE DILATOR. ENSURE THAT THE BALLOON IS COMPLETELY DEFLATED. THOROUGHLY LUBRICATE TRACHEOSTOMY TUBE ASSEMBLY.¿ TRACHEOSTOMY PROCEDURE ¿1. PALPATE LANDMARK STRUCTURES (THYROID NOTCH, CRICOID CARTILAGE) TO ASCERTAIN PROPER LOCATION FOR TRACHEOSTOMY TUBE PLACEMENT. ACCESS AND, ULTIMATELY, TUBE PLACEMENT IS IDEALLY MADE AT THE LEVEL BETWEEN THE FIRST AND SECOND TRACHEAL CARTILAGES OR BETWEEN THE SECOND AND THIRD TRACHEAL CARTILAGES WHENEVER FEASIBLE. 2. AFTER INTRODUCING LOCAL ANESTHESIA, MAKE A 1.5-2.0 CM SKIN INCISION (VERTICAL OR HORIZONTAL) AT THE CHOSEN INSERTION SITE. 3. IF DESIRED, USE A CURVED MOSQUITO CLAMP TO GENTLY DISSECT VERTICALLY AND TRANSVERSELY DOWN TO THE ANTERIOR TRACHEAL WALL. WITH A FINGERTIP, DISSECT THE FRONT OF THE TRACHEA, IN THE MIDLINE, FREE OF ANY TISSUES AND IDENTIFY THE CRICOID CARTILAGE. DISPLACE THE ISTHMUS OF THE THYROID DOWNWARD, IF PRESENT. NOTE: AN ADEQUATE SKIN INCISION AND BLUNT DISSECTION OF THE SUBCUTANEOUS TISSUE CAN MINIMIZE THE NEED FOR EXCESSIVE FORCE AND TORQUE THROUGHOUT THE PROCEDURE. EXCESSIVE FORCE AND ROTATION MAY LEAD TO LONG-TERM COMPLICATIONS." HOW SUPPLIED: ¿-UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE LIMITED INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS RELATED TO A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES. THERE ARE 100% INSPECTION ACTIVITIES IN PLACE TO IDENTIFY THIS FAILURE PRIOR TO DISTRIBUTION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.
CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. UPON FURTHER REVIEW, IT WAS DETERMINED THIS EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY OR REPORTABLE PRODUCT MALFUNCTION AS THERE IS NO INDICATION OF THE MALFUNCTION LEADING TO AN AE. IT WAS DETERMINED THAT IT IS NOT REASONABLE TO PRESUME THAT THE BENDING OF THE 14FR PUNCH DILATOR AND WIRE GUIDE WOULD CAUSE THE TRACHEOSTOMY PROCEDURE TO HAVE TO BE REPEATED IN THE OPERATING ROOM (OR). AS REPORTED, THE TRACHEOSTOMY TUBE WAS IN PLACE FOR 3 HOURS PRIOR TO THE RE-DO PROCEDURE IN THE OR. THEREFORE, THE PUNCH DILATOR AND WIRE GUIDE WERE ABLE TO FACILITATE PLACEMENT OF THE TRACHEOSTOMY TUBE. THESE TWO COMPONENTS WOULD HAVE BEEN REMOVED FROM THE PATIENT DURING THE INITIAL PLACEMENT PROCEDURE AND WOULD NOT HAVE CONTRIBUTED FOR THE NEED TO RE-DO THE PROCEDURE THREE HOURS LATER. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO THE REPORTED FAILURE MODE "14FR PUNCH DILATOR AND WIRE GUIDED KINKED", AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR, THE EVENT IS NOT REPORTABLE PER 21CFR PART 803.50.
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE IN THE CRITICAL CARE UNIT ON (B)(6) 2021, THE INTRODUCER DILATOR AND WIRE GUIDE BENT. IT WAS REPORTED THAT THE DEVICE WAS IN PLACE FOR APPROXIMATELY THREE HOURS. DUE TO THE DIFFICULTY WITH THE INTRODUCER DILATOR AND WIRE GUIDE, THE PATIENT WAS THEN TAKEN FOR AN OPEN TRACHEOSTOMY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENT AND SPECIFIC PRODUCT USED. HOWEVER, THE PHYSICIAN THAT PERFORMED THE PROCEDURE IS NO LONGER EMPLOYED BY THE FACILITY.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 934623 | JOH TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |