O2 CANNULA
Report
- Report Number
- 3004748541-2025-00146
- Event Type
- Injury
- Date Received
- December 18, 2025
- Date of Event
- November 13, 2025
- Report Date
- February 28, 2026
- Manufacturer
- SALTER LABS
- Product Code
- BYX
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18 DEC 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. NO PHOTOS, VIDEOS, OR SAMPLES WERE PROVIDED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. HOWEVER, THE EVENT DESCRIBED IS A KNOWN FAILURE MODE AND IS UNDER REVIEW; WE WILL CONTINUE TO MONITOR FOR TRENDS. INVESTIGATION CONCLUSION: D4; H2; H6. DEVICE HISTORY RECORD (DHR) REVIEW: NO LOT NUMBER WAS PROVIDED; THEREFORE, NO DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM REPORTED DATES 11/18/2023 THROUGH 11/18/2025, FOR PART NUMBER 001350 AND FAILURE MODE "A1202 - DECOUPLING, A1208 - FITTING PROBLEM, AND DISCONNECTION/CONNECTION ISSUE(S)". THERE WERE 21 OTHER COMPLAINT(S) REPORTED FOR THE SAME ISSUE AND PART NUMBER UNDER COMPLAINT-(B)(4) DURING THE SAME TIMEFRAME. SALES = (B)(4) EA. CALCULATED OCCURRENCE (P1) = (22 COMPLAINT(S) / (B)(4) EA SOLD) X 100 = (B)(4). OCCURRENCE RANKING = 1/5.
THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18 DEC 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL. INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT: (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.
IT WAS REPORTED THAT THE NEW TUBING DOES NOT STAY TOGETHER THEREFORE IT EASILY BECOMES DISCONNECTED.
IT WAS REPORTED THAT THE NEW TUBING DOES NOT STAY TOGETHER THEREFORE IT EASILY BECOMES DISCONNECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157780 | O2 CANNULA | U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING, VYNIL TI | BYX | SALTER LABS | 001350 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |