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Device brand name · Nebulizer direct patient inte
Hudson Nebulizer Adaptor 033 Sterile Japanese: medical device reports filed with FDA
190 reports name it, 2011–2021. Manufacturer given most often on reports: Teleflex Medical. Product code CAF.
- 190
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 100%
- classified as malfunction
- 85.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 190 reports that name the brand "Hudson Nebulizer Adaptor 033 Sterile Japanese" (nebulizer direct patient inte), received between July 2011 and October 2021; the manufacturer given most often on reports is Teleflex Medical. 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 (100%); across all nebulizer (direct patient interface) reports (product code CAF) death is recorded in 1.4% and malfunction in 85.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are connection problem (47.9%), tear, rip or hole in device packaging (9.5%) and disconnection (7.4%). The patient problems coded most often are no patient involvement and low 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 3,131 reports carrying product code CAF. 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 |
|---|---|---|---|
| Connection problema connection problem | 91 | 47.9% | 5.5% |
| Tear, rip or hole in device packaging | 18 | 9.5% | 1.6% |
| Disconnection | 14 | 7.4% | 2.6% |
| Fitting problem | 14 | 7.4% | 2.1% |
| Gas/air leak | 6 | 3.2% | 0.7% |
| Leak/splashthe device leaked | 6 | 3.2% | 6.9% |
| Loose or intermittent connection | 5 | 2.6% | 0.9% |
| Failure to deliverthe device did not deliver the dose or item | 4 | 2.1% | 13.4% |
| Fluid/blood leak | 4 | 2.1% | 1.9% |
| Unstable | 4 | 2.1% | 0.3% |
| Air leak | 3 | 1.6% | 0.5% |
| Detachment of device or device componentpart of the device came off | 3 | 1.6% | 1.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 1.1% | 3.9% |
| Improper flow or infusion | 2 | 1.1% | 1.4% |
| Mechanical problema mechanical problem | 2 | 1.1% | 1% |
| No flow | 2 | 1.1% | 3.7% |
| Other (for use when an appropriate device code cannot be identified) | 2 | 1.1% | 0.8% |
| Restricted flow rate | 2 | 1.1% | 1.3% |
| Breakthe device broke | 1 | 0.5% | 4.9% |
| Detachment of device component | 1 | 0.5% | 0.9% |
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 |
|---|---|---|
| No patient involvement | 81 | 42.6% |
| Low oxygen saturation | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hudson Nebulizer Adaptor 033 Sterile Japanese | Product code CAF | All MAUDE reports |
|---|---|---|---|
| Reports | 190 | 3,131 | 26,136,888 |
| Share of that pool | — | 6.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 14 | 9 |
| Classified as injury | 0% | 8.4% | 36.2% |
| Classified as malfunction | 100% | 85.1% | 62.3% |
| Filed by the manufacturer | 100% | 76% | 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 CAF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Hudson Micro Mist Nebulizer W/Elong | 264 | 0 | 0% |
| Hudson RCI | 224 | 121 | 1.3% |
| AirLife | 155 | 37 | 2.6% |
| Devilbiss | 436 | 9 | 3.9% |
| Envoy Aer Compressor 230v Aus 9153632953 | 155 | 0 | 0% |
| Drive | 701 | 20 | 4.4% |
| Vicks | 212 | 5 | 0.5% |
| 50psi Compressor Mobilaire 9153619938 | 232 | 0 | 0% |
| Softheat | 251 | 0 | 0.4% |
| Ventilator | 174 | 3 | 7.5% |
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 Hudson Nebulizer Adaptor 033 Sterile Japanese reports
How many FDA reports name Hudson Nebulizer Adaptor 033 Sterile Japanese?
190 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
connection problem (47.9%), tear, rip or hole in device packaging (9.5%), disconnection (7.4%), fitting problem (7.4%) and gas/air leak (3.2%). 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 Hudson Nebulizer Adaptor 033 Sterile Japanese 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.