Devices › Tubes, gastrointestinal (and accessories)
Device brand name · Tubes gastrointestinal and accessories
Halyard: medical device reports filed with FDA
156 reports name it, 2016–2026. Manufacturer given most often on reports: Avanos Medical. Product code KNT.
- 156
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 11
- reports, 12 months to August 2026
- 11 in the 12 months before
- 94.9%
- classified as malfunction
- 47% across the product code
- 1.3%
- classified as death, as reported
- 2 reports · not verified by FDA
156 medical device reports received by FDA name the brand "Halyard" (tubes gastrointestinal and accessories); the manufacturer given most often on reports is Avanos Medical; received from October 2016 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
11 reports arrived in the 12 months to August 2026, close to the 11 of 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 (94.9%), injury (3.8%) and death (1.3%); across all tubes, gastrointestinal (and accessories) reports (product code KNT) death is recorded in 2.4% and malfunction in 47%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are disconnection (16%), break (5.8%) and leak/splash (5.1%). The patient problems coded most often are death, foreign body in patient and aspiration/inhalation. 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 26,205 reports carrying product code KNT. 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 |
|---|---|---|---|
| Disconnection | 25 | 16% | 1.1% |
| Breakthe device broke | 9 | 5.8% | 7.5% |
| Leak/splashthe device leaked | 8 | 5.1% | 4.7% |
| Material integrity problema problem with the device material | 6 | 3.8% | 0.3% |
| Difficult to removethe device was hard to remove | 5 | 3.2% | 4% |
| Detachment of device or device componentpart of the device came off | 4 | 2.6% | 3.1% |
| Component missing | 3 | 1.9% | 0.3% |
| Device dislodged or dislocated | 3 | 1.9% | 1.4% |
| Gas/air leak | 3 | 1.9% | 0% |
| Burst container or vessel | 2 | 1.3% | 1% |
| Defective devicethe device was defective | 2 | 1.3% | 0.3% |
| Device contamination with chemical or other material | 2 | 1.3% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 1.3% | 0.9% |
| Fluid/blood leak | 2 | 1.3% | 4.5% |
| Material puncture/hole | 2 | 1.3% | 1.3% |
| Melted | 2 | 1.3% | 0% |
| Occlusion within devicethe device blocked | 2 | 1.3% | 2.3% |
| Stretched | 2 | 1.3% | 0.2% |
| Contamination | 1 | 0.6% | 0.1% |
| Deflation problem | 1 | 0.6% | 2% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 2 | 1.3% |
| Foreign body in patientpart of a device left in the patient | 2 | 1.3% |
| Aspiration/inhalation | 1 | 0.6% |
| Bradycardiaslow heart rate | 1 | 0.6% |
| Burn(s)a burn | 1 | 0.6% |
| Device embedded in tissue or plaque | 1 | 0.6% |
| Discomfortdiscomfort | 1 | 0.6% |
| Dyspneashortness of breath | 1 | 0.6% |
| Erythemaskin redness | 1 | 0.6% |
| Hypoxialow oxygen | 1 | 0.6% |
| Loss of pulse | 1 | 0.6% |
| Low blood pressure/ hypotension | 1 | 0.6% |
| Low oxygen saturation | 1 | 0.6% |
| No patient involvement | 1 | 0.6% |
| Pneumonialung infection | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Halyard | Product code KNT | All MAUDE reports |
|---|---|---|---|
| Reports | 156 | 26,205 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 13 | 24 | 9 |
| Classified as injury | 3.8% | 49% | 36.2% |
| Classified as malfunction | 94.9% | 47% | 62.3% |
| Filed by the manufacturer | 5.8% | 91% | 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 KNT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Duodopa Duopa | 5,925 | 484 | 2% |
| Abbvie Peg | 1,633 | 0 | 1.7% |
| Bard DigniShield Stool Management System | 750 | 94 | 0.7% |
| Kangaroo | 4,328 | 117 | 0.2% |
| EndoVive Safety PEG Kit | 650 | 23 | 0.8% |
| EndoVive Standard PEG Kit | 534 | 15 | 2.1% |
| Corflo Cubby Low Profile Gastrostomy Device | 440 | 0 | 0% |
| Tube Gastrointestinal And Access | 448 | 0 | 1.1% |
| Endovive Jejunal Feeding Tube | 422 | 0 | 0.2% |
| Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit | 333 | 0 | 0.9% |
| Endovive Securi-T | 264 | 0 | 0.4% |
| Abbvie J | 263 | 0 | 6.8% |
| Endovive Two-Port Ttp Jejunal Feeding Tube Cap | 262 | 0 | 1.5% |
| CORTRAK 2 Enteral Access System | 190 | 37 | 14.7% |
| Flexi-Seal Fms | 195 | 0 | 1.5% |
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 Halyard reports
How many FDA reports name Halyard?
156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 11 in the latest 12 months.
What kinds of events are reported?
malfunction (94.9%), injury (3.8%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
disconnection (16%), break (5.8%), leak/splash (5.1%), material integrity problem (3.8%) and difficult to remove (3.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (5.8%) and voluntary reports (3.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Halyard 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.