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Green - 15ft Oxygen Supply Tube RES3015GRecalls & reported problems

Sunset Healthcare Solutions, Inc. · Green - 15ft Oxygen Supply Tube · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848530061067), received between Feb 12, 2019 and Feb 12, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Device problems

  • Fluid/Blood Leak1
  • Material Puncture/Hole1

Patient problems

  • Pain1
  • Peeling1
  • Skin Inflammation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 12, 2019Fluid/Blood Leak; Material Puncture/Hole

    HAD BEEN SUFFERING WORSENING SINUS RELATED ISSUES. SEEN N.P. ON (B)(6) 2019 WHO ORDERED NASAL SWAB FOR CEREBRAL SPINAL FLUID. ON (B)(6) 2019, MY BI-PAP HAD INCREASED TO 2.5 PER HOUR . MY NOSE WAS RED, PEELING AND PAINFUL. ON (B)(6) 2018, I CHANGED OUT ALL MY OXYGEN, NEBULIZER , BI-PAP EQUIPMENT AND FILTERS. I RECHECKED THE EXTENSION TUBING ON THE OXYGEN CONCENTRATION. THE TUBING WAS FULL OF PIN HOLES AT THE CONNECTION END ON BOTH SIDES FOR ABOUT 12 INCHES. I CHANGED IT AND GOT MORE TUBING FROM (B)(6), MY DME COMPANY. MY BI-PAP SETTINGS IMPROVED TO 0.6-1.0 AND MY SINUS SYMPTOMS STOPPED. TODAY, MY NOSE IS STARTING TO DRIP AGAIN. I AM WHEEZING. MY BI-PAP SETTINGS ARE BACK UP TO 2.5, I CHECKED THE EXTENSION TUBING ON MY OXYGEN CONCENTRATION. I HAVE THE SAME SITUATION. THE TUBING IS FULL OF PIN HOLES AT THE CONNECTION ENDS FOR ABOUT 12 INCHES. I OPENED A NEW EXTENSION TUBING TO INSPECT IT. THE TUBING ITSELF HAS AIR BUBBLES VISIBLE IN IT , TINY ONES. I BELIEVE THAT WITH USE OF THE TUBING AND TIME THAT THESE AIR BUBBLES/WEAK SEAMS ARE POPPING OPEN CREATING PIN HOLES IN THE EXTENSION TUBING. I USED TWO DIFFERENT TYPES OF TUBING. ONE FROM SALTER LABS REF 2025G-25. ONE FROM SUNSET RES3015G.

    Patient problems: Pain; Peeling; Skin Inflammation

    MAUDE report 8336387 ↗

Other Tubing, Pressure And Accessories devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.