Tubing, pressure and accessories: medical device reports filed with FDA

523 reports carry this product code, 1992–2026; 4 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

523
reports with this product code: 0% of all MAUDE reports; 123
reports, 12 months to August 2026: 41 in the 12 months before; 77.8%
classified as malfunction: 62.3% across all reports; 2.7%
classified as death, as reported: 0.9% across all reports

Product code BYX is FDA's classification for "Tubing, pressure and accessories" (anesthesiology panel), a class 1 device. 523 medical device reports carry this product code, 0% of the MAUDE database, from December 1992 to August 2026.

123 reports arrived in the 12 months to August 2026, up 200% from 41 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 (77.8%), injury (15.1%) and death (2.7%). 4 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Salter Labs	9	15	0.6%	84.5%
Hudson RCI	2	121	1.3%	84.4%
Hled	1	18	0%	98.8%
Pressure Monitoring Kit	1	0	0.7%	90.4%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medex	47	9%
Maquet Sas	41	7.8%
Merit Medical Systems	12	2.3%
Hamilton Medical	7	1.3%
Maquet	6	1.1%
Fisher & Paykel Healthcare	5	1%
Smiths Medical International	2	0.4%
Allegiance Healthcare	1	0.2%
Draeger Medical	1	0.2%
Edwards Lifesciences	1	0.2%
Liebel-Flarsheim	1	0.2%
Resmed	1	0.2%
Richard Wolf	1	0.2%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death2.7%14

Injury15.1%79

Malfunction77.8%407

Other2.1%11

Not given2.3%12

Who filed

Manufacturer report85.9%449

Voluntary report6.1%32

User facility report0%0

Distributor report1.7%9

Not given6.3%33

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Material twisted/bent	58	11.1%
Loose or intermittent connection	37	7.1%
Crackthe device cracked	33	6.3%
Breakthe device broke	31	5.9%
Connection problema connection problem	30	5.7%
Detachment of device component	28	5.4%
Detachment of device or device componentpart of the device came off	26	5%
Disconnection	21	4%
Leak/splashthe device leaked	20	3.8%
Air leak	16	3.1%
Component falling	15	2.9%
Incomplete or inadequate connection	15	2.9%
Replace	14	2.7%
Gas/air leak	13	2.5%
Material separation	13	2.5%
Kinkedthe tube or line kinked	12	2.3%
Burst container or vessel	10	1.9%
Fluid/blood leak	10	1.9%
Component(s), broken	9	1.7%
Material deformation	9	1.7%

Questions about tubing, pressure and accessories reports

What is product code BYX?

FDA's classification code for "Tubing, pressure and accessories", class 1, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

523 reports through August 2026, 123 of them in the latest 12 months.

Which brands appear most often?

Salter Labs (9), Hudson RCI (2), Hled (1) and Pressure Monitoring Kit (1). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.