AIRLIFE
Report
- Report Number
- 8030673-2024-01035
- Event Type
- Injury
- Date Received
- November 27, 2024
- Date of Event
- June 30, 2025
- Report Date
- August 1, 2025
- Manufacturer
- AIRLIFE
- Product Code
- OGG
- UDI-DI
- 10190752158450
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H: CATHETER 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 26 NOV 2024 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 SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF NURSE NOTICE THAT THE CATHETER HAS GOTTEN LOOSE FROM THE VERSO ADAPTER. WHEN TRYING TO PUT IT BACK SHE NOTICE THAT THE TIP OF THE CATHETER HAS BROKEN LOOSE AND ARE STUCK INSIDE THE VERSO ADAPTER REGARDING PRODUCT CSC112 WAS NOT CONFIRMED. THE POSSIBLE CAUSES FOR FAILURE COULD BE EXTERNAL FORCE BY USER'S EQUIPMENT OR IMPROPER CONNECTION OF CATHETER AND ADAPTER. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE MIDDLE WHICH REQUIRED CAPA OPTION AND REPORTING TO THE CARB REVIEW BOARD FOR EVALUATION (THE COMPLAINT HAVE BEEN ENTERED INTO ELG-20026-C1 AS (B)(4)). THERE HAVE BENE 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PROCEEDING THE REPORTING OF THIS ISSUE. COMPLAINT WILL CONTINUE TO BE MONITORED FOR POSSIBLE TREND.
H^: CATHETER. 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 26 NOV 2024 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 (B)(4). 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 (B)(4) . (B)(4). 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 (B)(4) 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 (B)(4). PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.
UPON FURTHER REVIEW THE REPORT NEEDS TO BE UPDATED TO REFLECT THE YEAR THE REPORT WAS RECEIVED (2025); A NEW INITIAL REPORT WILL BE SUBMITTED UNDER NEW FDA MW REPORT MW 8030673-2025-00028; NO FURTHER INFORMATION CONCERNING THIS REPORTED EVENT WILL BE SUBMITTED IN FDA MW REPORT MW: 8030673-2024-01035. ALL INFORMATION REASONABLY KNOWN AS OF 01 AUG 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
IT WAS REPORTED THAT "THE CATHETER HAS GOTTEN LOOSE FROM THE VERSO ADAPTER. WHEN TRYING TO PUT IT BACK SHE NOTICE THAT THE TIP OF THE CATHETER HAS BROKEN LOOSE AND ARE STUCK INSIDE THE VERSO ADAPTER".
IT WAS REPORTED THAT "THE CATHETER HAS GOTTEN LOOSE FROM THE VERSO ADAPTER. WHEN TRYING TO PUT IT BACK SHE NOTICE THAT THE TIP OF THE CATHETER HAS BROKEN LOOSE AND ARE STUCK INSIDE THE VERSO ADAPTER".
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030673-2024-01036 FOR THE SECOND REPORT. IT WAS REPORTED AFTER THE RESPIRATORY THERAPIST (RT) ESTABLISHED THE UNIT ON THE PATIENT IN THE INTENSIVE CARE UNIT (ICU), THE NURSE NOTICED THE PATIENT'S OXYGEN (O2) SATURATION DROPPED. THE RT WAS CALLED AND THE DEVICE WAS REMOVED AS THE PATIENT WAS STRUGGLING TO BREATHE AND THEIR SATURATIONS WERE SO LOW THEY HAD TO BE INTUBATED. IT WAS ADDITIONALLY REPORTED, THE PATIENT EXPERIENCED AN UNSPECIFIED LIFE-THREATENING INJURY; NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2452640 | AIRLIFE | PREFILL NEBULIZER KIT | OGG | AIRLIFE | CK0010 | 004298169 | 10190752158450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |