Devices › Cannula, nasal, oxygen
Device brand name · Cat
Optiflow Junior Interface: medical device reports filed with FDA
246 reports name it, 2012–2024. Manufacturer given most often on reports: Fisher & Paykel Healthcare. Product code CAT.
- 246
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.8%
- classified as malfunction
- 83.4% across the product code
- 0.4%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 246 reports that name the brand "Optiflow Junior Interface" (cat), received between October 2012 and April 2024; the manufacturer given most often on reports is Fisher & Paykel Healthcare. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.8%), injury (0.8%) and death (0.4%); across all cannula, nasal, oxygen reports (product code CAT) death is recorded in 1.7% and malfunction in 83.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (23.6%), device handling problem (15%) and detachment of device component (11%). The patient problems coded most often are low oxygen saturation, no patient involvement and high oxygen saturation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,798 reports carrying product code CAT. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 58 | 23.6% | 18.4% |
| Device handling problem | 37 | 15% | 6.8% |
| Detachment of device component | 27 | 11% | 5% |
| Detachment of device or device componentpart of the device came off | 21 | 8.5% | 10.7% |
| Material split, cut or torn | 21 | 8.5% | 5.6% |
| Device issuea problem with the device | 19 | 7.7% | 4.8% |
| Disconnection | 16 | 6.5% | 6.8% |
| Material separation | 9 | 3.7% | 2.9% |
| Failure to adhere or bond | 8 | 3.3% | 0.4% |
| Leak/splashthe device leaked | 8 | 3.3% | 2.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 2% | 1.3% |
| Device slipped | 4 | 1.6% | 0.4% |
| Loss of or failure to bond | 4 | 1.6% | 0.4% |
| Material integrity problema problem with the device material | 4 | 1.6% | 1.7% |
| Extrusion | 3 | 1.2% | 0.1% |
| Hole in material | 3 | 1.2% | 1.9% |
| Improper or incorrect procedure or method | 3 | 1.2% | 1% |
| Unintended movement | 3 | 1.2% | 0.2% |
| Defective devicethe device was defective | 2 | 0.8% | 0.4% |
| Device dislodged or dislocated | 2 | 0.8% | 0.4% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Low oxygen saturation | 12 | 4.9% |
| No patient involvement | 3 | 1.2% |
| High oxygen saturation | 2 | 0.8% |
| Increased respiratory rate | 2 | 0.8% |
| Pressure sore/ulcer | 2 | 0.8% |
| Skin tears | 2 | 0.8% |
| Asphyxia | 1 | 0.4% |
| Burn(s)a burn | 1 | 0.4% |
| Deaththe patient died; cause not stated by this term | 1 | 0.4% |
| Extubate | 1 | 0.4% |
| Hemorrhage/blood loss/bleeding | 1 | 0.4% |
| Injurya physical injury | 1 | 0.4% |
| Laceration(s) | 1 | 0.4% |
| Painpain, site not specified | 1 | 0.4% |
| Pneumothoraxa collapsed lung | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Optiflow Junior Interface | Product code CAT | All MAUDE reports |
|---|---|---|---|
| Reports | 246 | 1,798 | 26,136,888 |
| Share of that pool | — | 13.7% | 0% |
| Classified as death, per 1,000 reports | 4 | 17 | 9 |
| Classified as injury | 0.8% | 11.5% | 36.2% |
| Classified as malfunction | 98.8% | 83.4% | 62.3% |
| Filed by the manufacturer | 100% | 88.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code CAT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Adult Nasal Interface | 298 | 0 | 2.3% |
| Salter Labs | 168 | 15 | 0.6% |
| Fisher and Paykel Healthcare | 333 | 134 | 0% |
| AirLife | 155 | 37 | 2.6% |
| Hudson RCI | 224 | 121 | 1.3% |
| Optiflow + Adult Nasal Cannula | 423 | 4 | 2.6% |
| Shiley | 12,236 | 1,513 | 1.1% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Optiflow Junior Interface reports
How many FDA reports name Optiflow Junior Interface?
246 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (98.8%), injury (0.8%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (23.6%), device handling problem (15%), detachment of device component (11%), detachment of device or device component (8.5%) and material split, cut or torn (8.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Optiflow Junior Interface was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.