BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
Report
- Report Number
- 1820334-2022-00104
- Event Type
- Injury
- Date Received
- January 24, 2022
- Date of Event
- January 2, 2022
- Report Date
- February 7, 2022
- Manufacturer
- COOK INC
- Product Code
- JOH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BRAND NAME- (B)(6). 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.
BRAND NAME- G57716-C-PTISY-100-HC-G-NA-FLEX7.5 OR G57717-C-PTISY-100-HC-G-NA-FLEX8.5. 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.
CORRECTION: IT WAS REPORTED DURING COMMUNICATION WITH THE CUSTOMER THAT THE COMPLAINT EVENT DID NOT INVOLVE A COOK PRODUCT. AS SUCH, THERE IS NO ALLEGED DEFICIENCY IN IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF A COOK INC MANUFACTURED DEVICE. THEREFORE, THIS EVENT NO LONGER MEETS THE SET CRITERIA FOR A REPORTABLE EVENT PER 21 CFR PART 820; NO FURTHER REPORTS REGARDING THIS EVENT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CUFF OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY "POPPED". THE DEVICE WAS PLACED WITHOUT INCIDENT DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE IN THE OPERATING ROOM. FOLLOWING THE PROCEDURE THE PATIENT WAS TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT (MICU). A "FEW HOURS LATER" AN AIR LEAK IN THE TRACHEOSTOMY TUBE CUFF WAS OBSERVED. THE CLINICIAN ADDED ADDITIONAL AIR INTO THE CUFF; HOWEVER, THE AIR LEAK WAS NOT RESOLVED. SUBSEQUENTLY, THE DEVICE WAS REMOVED AND REPLACED IN THE ICU WITH AN UNKNOWN 8.5 TRACHEOSTOMY TUBE AND THE AIR LEAK WAS TEMPORARILY RESOLVED. A "FEW HOURS LATER" AN AIR LEAK IN THE UNKNOWN TRACHEOSTOMY TUBE CUFF WAS OBSERVED. THE DEVICE WAS THEN REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT. NO FURTHER AIR LEAK WAS OBSERVED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CUFF OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY "POPPED". THE DEVICE WAS PLACED WITHOUT INCIDENT DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE IN THE OPERATING ROOM. FOLLOWING THE PROCEDURE THE PATIENT WAS TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT (MICU). A "FEW HOURS LATER" AN AIR LEAK IN THE TRACHEOSTOMY TUBE CUFF WAS OBSERVED. THE CLINICIAN ADDED ADDITIONAL AIR INTO THE CUFF; HOWEVER, THE AIR LEAK WAS NOT RESOLVED. SUBSEQUENTLY, THE DEVICE WAS REMOVED AND REPLACED IN THE ICU WITH AN UNKNOWN 8.5 TRACHEOSTOMY TUBE AND THE AIR LEAK WAS TEMPORARILY RESOLVED. A "FEW HOURS LATER" AN AIR LEAK IN THE UNKNOWN TRACHEOSTOMY TUBE CUFF WAS OBSERVED. THE DEVICE WAS THEN REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT. NO FURTHER AIR LEAK WAS OBSERVED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
ADDITIONAL INFORMATION RECEIVED ON 21JAN2022 CONFIRMED THAT THE TRACHEOSTOMY TUBE IN THIS EVENT IS NOT A COOK DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1999512 | BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY | JOH TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |