PENDING HCSU4514Recalls & reported problems
Medline Industries, Inc. · CANNULA,ADULT,SOFT-TOUCH,7'TUBE,UC · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389966143), received between Aug 21, 2019 and Nov 2, 2022 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Bone Fracture(s)1
- Tissue Breakdown1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, THE PATIENT HAD BEEN WEARING THE NASAL CANNULA FOR 5 DAYS WHEN A 'RIGHT EAR STAGE 3 PRESSURE INJURY AND LEFT EAR STAGE 2 PRESSURE INJURY' WAS IDENTIFIED 'WHERE THE NASAL CANNULA RESTS AGAINST THE SKIN'.
Patient problems: Tissue Breakdown
MAUDE report 15718066 ↗InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT TANGLED UP IN THE 25 FEET OXYGEN TUBING CONNECTOR AND 7 FEET NASAL CANNULA. PATIENT SUSTAINED RIGHT PATELLAR FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 8915387 ↗
Other CANNULA, NASAL, OXYGEN devices
- Fisher & Paykel Healthcare OPT844Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen39 reports
- Fisher and Paykel Healthcare OPT312Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen22 reports
- Fisher and Paykel Healthcare OPT314Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen17 reports
- O2 Cannula 001366Salter Labs · Cannula, Nasal, Oxygen10 reports
- O2 Cannula 001365Salter Labs · Cannula, Nasal, Oxygen9 reports
- N/A 16SOFT-4Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- N/A 1053-7Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- Fisher & Paykel Healthcare OPT842Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.