Devices › Tubes, gastrointestinal (and accessories)
Device brand name · Tubes gastrointestinal and accessories
Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit: medical device reports filed with FDA
333 reports name it, 2009–2018. Manufacturer given most often on reports: Boston Scientific - Spencer. Product code KNT.
- 333
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 55.9%
- classified as malfunction
- 47% across the product code
- 0.9%
- classified as death, as reported
- 3 reports · not verified by FDA
333 medical device reports received by FDA name the brand "Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit" (tubes gastrointestinal and accessories); the manufacturer given most often on reports is Boston Scientific - Spencer; received from December 2009 to July 2018. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (55.9%), injury (43.2%) and death (0.9%); 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 occlusion within device (13.5%), difficult to advance (10.5%) and detachment of device component (9.6%). The patient problems coded most often are pain, inflammation and peritonitis. 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
No report naming Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit was received in the five years to August 2026; the latest was received in July 2018.
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 |
|---|---|---|---|
| Occlusion within devicethe device blocked | 45 | 13.5% | 2.3% |
| Difficult to advance | 35 | 10.5% | 0.6% |
| Detachment of device component | 32 | 9.6% | 4.6% |
| Breakthe device broke | 29 | 8.7% | 7.5% |
| Migration or expulsion of device | 25 | 7.5% | 1.9% |
| Human-device interface problem | 18 | 5.4% | 0.4% |
| Torn material | 14 | 4.2% | 0.5% |
| Entrapment of device | 13 | 3.9% | 0.3% |
| Hole in material | 13 | 3.9% | 0.5% |
| Detachment of device or device componentpart of the device came off | 7 | 2.1% | 3.1% |
| Difficult to open or close | 6 | 1.8% | 0.2% |
| Fluid/blood leak | 6 | 1.8% | 4.5% |
| Insufficient device problem information | 6 | 1.8% | 3.7% |
| Material deformation | 6 | 1.8% | 0.2% |
| Difficult to position | 5 | 1.5% | 0.2% |
| Kinkedthe tube or line kinked | 5 | 1.5% | 1% |
| Leak/splashthe device leaked | 5 | 1.5% | 4.7% |
| Unraveled material | 5 | 1.5% | 0.2% |
| Device contamination with biological material | 4 | 1.2% | 0% |
| Split | 4 | 1.2% | 0.2% |
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 |
|---|---|---|
| Painpain, site not specified | 11 | 3.3% |
| Inflammationinflammation | 9 | 2.7% |
| Peritonitis | 5 | 1.5% |
| Abdominal painstomach or belly pain | 3 | 0.9% |
| Deaththe patient died; cause not stated by this term | 3 | 0.9% |
| Granuloma | 3 | 0.9% |
| Abscessa collection of pus | 2 | 0.6% |
| Blood loss | 2 | 0.6% |
| Fluid discharge | 2 | 0.6% |
| Pneumonialung infection | 2 | 0.6% |
| Ulcer | 2 | 0.6% |
| Alteration in body temperature | 1 | 0.3% |
| Bacterial infectiona bacterial infection | 1 | 0.3% |
| Cardiac arrestthe heart stopped | 1 | 0.3% |
| Device embedded in tissue or plaque | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit | Product code KNT | All MAUDE reports |
|---|---|---|---|
| Reports | 333 | 26,205 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 9 | 24 | 9 |
| Classified as injury | 43.2% | 49% | 36.2% |
| Classified as malfunction | 55.9% | 47% | 62.3% |
| Filed by the manufacturer | 100% | 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 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% |
| Replacement Tube | 183 | 0 | 0.5% |
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 Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit reports
How many FDA reports name Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit?
333 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 (55.9%), injury (43.2%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
occlusion within device (13.5%), difficult to advance (10.5%), detachment of device component (9.6%), break (8.7%) and migration or expulsion of device (7.5%). 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 Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit 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.