SALTER O2 CANNULA

Additional Manufacturer Narrative

H6: (APPROPRIATE TERM/CODE NOT AVAILABLE): MANUALLY OPENED THE KINK AND HELD IT OPEN WITH THEIR FINGERS THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; ADDITIONALLY, NO PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE WAS PROVIDED BY THE REPORTER. IN THE ABSENCE OF A PHOTO OR VIDEO, THE COMPLAINT COULD NOT CONFIRMED; WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 02 JUL 2026 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 21CFR803, 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.

Description of Event or Problem

THE HEALTHCARE PROVIDER (HCP) NOTED THAT THE TUBING WAS KINKED RIGHT ABOVE THE NIPPLE WHERE IT FIT ONTO THE OXYGEN (O2) TANK AND AN UNSPECIFIED DESATURATION EVENT OCCURRED. THE HCP MANUALLY OPENED THE KINK AND HELD IT OPEN WITH THEIR FINGERS AND THE O2 SATURATION RATE OF THE PATIENT RETURNED TO EXPECTED LEVELS. MINIMAL HARM REPORTED. ADDITIONAL INFORMATION RECEIVED 16JUN2026 REPORTED, THE RESIDENT RECOVERED FAIRLY QUICKLY AFTER THE PROBLEM WAS ADDRESSED.