Adult Soft Tip Cannula with 7' 85 Shore Green Tubing 0556Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00709078002960), received between Nov 3, 2023 and Jul 25, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 3004748541-2025-00037 FOR THE SECOND REPORT. IT WAS REPORTED: REPORTED: [WHILE] GIVING VETERAN HIS MEDICATION AND TALKING TO VETERAN WRITER NOTICED VETERAN'S OXYGEN TUBING PRONG BY [NOSE] WAS PINCHED. WRITER ASKED VETERAN IF VET COULD FEEL AIR COMING OUT. VETERAN TESTED IT AND SAID NO. THIS HAS BEEN HAPPENING VERY FREQUENTLY. WRITER GOT A NEW NASAL CANNULA AND THAT ONE WAS THE SAME WAY, FINALLY GOT ANOTHER ONE AND IT WAS USABLE. IT WAS ADDITIONALLY REPORTED, THE PATIENT WAS NOT RECEIVING THE CORRECT DOSE OF OXYGEN THROUGH CANNULA. ON THE SPOT CORRECTION BY NURSING. NO ADVERSE AFFECTS TO PATIENT WERE RECORDED. FDA USER FACILITY MW REPORT MW5172094, RECEIVED ON 15JUL2025 REPORTED, VETERAN IS ON 3L OF O2 AND NOW IS ABLE TO GET THE AMOUNT OF OXYGEN VET NEEDS. REF REPORT: MW5172095. [THERE WAS NO REPORTED INJURY.]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22617428 ↗
• MalfunctionJul 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00036 FOR THE FIRST REPORT. IT WAS REPORTED: REPORTED: [WHILE] GIVING VETERAN HIS MEDICATION AND TALKING TO VETERAN WRITER NOTICED VETERAN'S OXYGEN TUBING PRONG BY [NOSE] WAS PINCHED. WRITER ASKED VETERAN IF VET COULD FEEL AIR COMING OUT. VETERAN TESTED IT AND SAID NO. THIS HAS BEEN HAPPENING VERY FREQUENTLY. WRITER GOT A NEW NASAL CANNULA AND THAT ONE WAS THE SAME WAY, FINALLY GOT ANOTHER ONE AND IT WAS USABLE. IT WAS ADDITIONALLY REPORTED, THE PATIENT WAS NOT RECEIVING THE CORRECT DOSE OF OXYGEN THROUGH CANNULA. ON THE SPOT CORRECTION BY NURSING. NO ADVERSE AFFECTS TO PATIENT WERE RECORDED. FDA USER FACILITY MW REPORT MW5172094, RECEIVED ON 15JUL2025 REPORTED, VETERAN IS ON 3L OF O2 AND NOW IS ABLE TO GET THE AMOUNT OF OXYGEN VET NEEDS. REF REPORT: MW5172095. [THERE WAS NO REPORTED INJURY.]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22617400 ↗
• MalfunctionNov 22, 2023Material Integrity Problem; Material Integrity Problem

  TUBING WAS BLACK.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 18196864 ↗
• MalfunctionNov 22, 2023Leak/Splash; Leak/Splash

  CANNULAS ARE LEAKING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18196862 ↗
• MalfunctionNov 3, 2023Contamination; Contamination

  DESCRIBE THE EVENT OR PROBLEM: 50 MINUTES AFTER PT. EXPIRED, NOTED A A BURNT SMELL IN THE HALLWAY IN AICU ACROSS THE SECOND STATION, THE STAFF CHECKED AT THE NEARBY ROOMS WHERE THE BURNT SMELL WAS SENSED. IN AICU, IN THE HEAD OF THE DECEASED PATIENT, FOUND A NASAL CANNULA ON THE TOP FRONTAL AREA AND THE PRONGS OF THE NASAL CANNULA HAS A STRAND OF BURNT HAIR SUCKED INTO IT, WHERE THE BURNT SMELL WAS COMING FROM. THE O2 SUPPLY FROM THE DELIVERY METER WHERE THE CANNULA WAS ATTACHED WAS IMMEDIATELY TURNED OFF. NO BURNT WOUND WAS NOTED ON THE HEAD UPON INSPECTION HOWEVER NOTED 2 BURNT MARKINGS/HOLES ON THE PILLOW CASE AND PLASTIC COVER OF THE PILLOW. PICTURES TAKEN, NASAL CANNULA AND PILLOWS WITH PILLOW CASE SAVED AND CONTAINED IN A PLASTIC BAG. PROVIDER NOTIFIED AND ASSESSED THE EVENT AT BEDSIDE. 1. O2 SUPPLY TO THE NASAL CANNULA WAS TURNED OFF AND THE THE NC DEVICE WAS CONTAINED IN A SPECIMEN PLASTIC BAG AND LABELLED. 2. ASSESSED HEAD AND BACK OF THE BODY, NO BURNT WOUND NOTED. 3. PROVIDER NOTIFIED WHO CAME AND ASSESSED THE EVENT. 4. THE PILLOWCASE AND PILLOW WERE CONTAINED IN A PLASTIC BAG. 5. THE EVENT WAS DOCUMENTED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : NO PROCEDURE. PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18068630 ↗