N/A 1616-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607411100710), received between Nov 21, 2024 and Nov 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Break; Material Twisted/Bent; Material Too Soft/Flexible; Break; Material Twisted/Bent; Material Too Soft/Flexible

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3000219639-2024-00133 FOR THE FIRST REPORT. REFER TO 3000219639-2024-00135 FOR THE THIRD REPORT. IT WAS REPORTED, THE USER STRUGGLED TO USE THE CANNULA DUE TO [ITS'] THINNESS; THE LEFT SIDE KINKED AND FOLDED/BENT OVER AND BLOCKED THE AIRFLOW. IT WAS ADDITIONALLY REPORTED THE CANNULA DID NOT FIT ON THE NOSE AND WHEN WORN THE TUBING SNAPPED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20746878 ↗
• MalfunctionNov 21, 2024Break; Material Twisted/Bent; Material Too Soft/Flexible; Break; Material Twisted/Bent; Material Too Soft/Flexible

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3000219639-2024-00134 FOR THE SECOND REPORT. REFER TO 3000219639-2024-00135 FOR THE THIRD REPORT. IT WAS REPORTED, THE USER STRUGGLED TO USE THE CANNULA DUE TO [ITS'] THINNESS; THE LEFT SIDE KINKED AND FOLDED/BENT OVER AND BLOCKED THE AIRFLOW. IT WAS ADDITIONALLY REPORTED THE CANNULA DID NOT FIT ON THE NOSE AND WHEN WORN THE TUBING SNAPPED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20746869 ↗
• MalfunctionNov 21, 2024Break; Material Twisted/Bent; Material Too Soft/Flexible; Break; Material Twisted/Bent; Material Too Soft/Flexible

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3000219639-2024-00133 FOR THE FIRST REPORT. REFER TO 3000219639-2024-00134 FOR THE SECOND REPORT. IT WAS REPORTED, THE USER STRUGGLED TO USE THE CANNULA DUE TO [ITS'] THINNESS; THE LEFT SIDE KINKED AND FOLDED/BENT OVER AND BLOCKED THE AIRFLOW. IT WAS ADDITIONALLY REPORTED THE CANNULA DID NOT FIT ON THE NOSE AND WHEN WORN THE TUBING SNAPPED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20746848 ↗