Devices › Catheter and tip, suction
Device brand name · Jol catheter and tip suction
Wayne Pneumothorax Set: medical device reports filed with FDA
166 reports name it, 2009–2026. Manufacturer given most often on reports: Cook. Product code JOL.
- 166
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 13
- reports, 12 months to August 2026
- 9 in the 12 months before
- 75.9%
- classified as malfunction
- 86.4% across the product code
- 1.2%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 166 reports that name the brand "Wayne Pneumothorax Set" (jol catheter and tip suction), received between January 2009 and August 2026; the manufacturer given most often on reports is Cook. Spellings of one product vary from report to report.
13 reports arrived in the 12 months to August 2026, up 44% from 9 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 (75.9%), injury (22.3%) and death (1.2%); across all catheter and tip, suction reports (product code JOL) death is recorded in 0.6% and malfunction in 86.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unraveled material (10.8%), device contaminated during manufacture or shipping (9%) and material separation (9%). The patient problems coded most often are no patient involvement, pneumothorax and internal organ perforation. 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 2,801 reports carrying product code JOL. 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 |
|---|---|---|---|
| Unraveled material | 18 | 10.8% | 1.7% |
| Device contaminated during manufacture or shipping | 15 | 9% | 1.6% |
| Material separation | 15 | 9% | 4.6% |
| Leak/splashthe device leaked | 10 | 6% | 9.3% |
| Difficult to removethe device was hard to remove | 7 | 4.2% | 0.7% |
| Detachment of device or device componentpart of the device came off | 5 | 3% | 3.6% |
| Disconnection | 5 | 3% | 1.3% |
| Fitting problem | 4 | 2.4% | 0.2% |
| Material frayed | 4 | 2.4% | 0.1% |
| Breakthe device broke | 3 | 1.8% | 8% |
| Contamination /decontamination problem | 3 | 1.8% | 0.3% |
| Delivered as unsterile product | 3 | 1.8% | 0.2% |
| Device contamination with chemical or other material | 3 | 1.8% | 11.2% |
| Fluid/blood leak | 3 | 1.8% | 2.7% |
| Separation problem | 3 | 1.8% | 0.1% |
| Difficult to advance | 2 | 1.2% | 0% |
| Gas/air leak | 2 | 1.2% | 0.2% |
| Material deformation | 2 | 1.2% | 0.7% |
| Material split, cut or torn | 2 | 1.2% | 0.1% |
| Connection problema connection problem | 1 | 0.6% | 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 |
|---|---|---|
| No patient involvement | 23 | 13.9% |
| Pneumothoraxa collapsed lung | 8 | 4.8% |
| Internal organ perforation | 2 | 1.2% |
| Adult respiratory distress syndrome | 1 | 0.6% |
| Cardiac perforation | 1 | 0.6% |
| Cardiac tamponade | 1 | 0.6% |
| Extravasation | 1 | 0.6% |
| Hemorrhage/blood loss/bleeding | 1 | 0.6% |
| Low blood pressure/ hypotension | 1 | 0.6% |
| Painpain, site not specified | 1 | 0.6% |
| Vascular dissection | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Wayne Pneumothorax Set | Product code JOL | All MAUDE reports |
|---|---|---|---|
| Reports | 166 | 2,801 | 26,136,888 |
| Share of that pool | — | 5.9% | 0% |
| Classified as death, per 1,000 reports | 12 | 6 | 9 |
| Classified as injury | 22.3% | 11% | 36.2% |
| Classified as malfunction | 75.9% | 86.4% | 62.3% |
| Filed by the manufacturer | 98.8% | 89.4% | 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 JOL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| J-Vac Resv 150 Ml | 520 | 44 | 0% |
| J-Vac Resv 300 Ml | 345 | 27 | 0% |
| Tbd | 622 | 8 | 0.6% |
| J-Vac Reservior Bulb 100 Cc | 150 | 1 | 0% |
| Halyard | 156 | 11 | 1.3% |
| J-VAC Reservoir | 719 | 16 | 0.4% |
| J-Vac Reservoirs | 218 | 0 | 0% |
| 4 0mm 90-S Max Serfas Energy Suction Probe | 281 | 0 | 0% |
| Medline | 26,935 | 26,184 | 0.1% |
| Argyle | 871 | 60 | 1% |
| Cardinal Health | 589 | 185 | 0.2% |
| Kendall | 213 | 23 | 2.3% |
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 Wayne Pneumothorax Set reports
How many FDA reports name Wayne Pneumothorax Set?
166 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.
What kinds of events are reported?
malfunction (75.9%), injury (22.3%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unraveled material (10.8%), device contaminated during manufacture or shipping (9%), material separation (9%), leak/splash (6%) and difficult to remove (4.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Wayne Pneumothorax Set 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.