Stopcock, i.v. set: medical device reports filed with FDA

6,009 reports carry this product code, 1992–2026; 17 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.

6,009
reports with this product code: 0% of all MAUDE reports; 874
reports, 12 months to August 2026: 917 in the 12 months before; 92.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

Product code FMG is FDA's classification for "Stopcock, i.v. set" (general Hospital panel), a class 2 device. 6,009 medical device reports carry this product code, 0% of the MAUDE database, from April 1992 to August 2026.

874 reports arrived in the 12 months to August 2026, close to the 917 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 (92.7%), injury (6%) and death (0.4%). 17 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
Bd Connecta Stopcock	288	0	0%	98.4%
Access	222	0	0%	98.7%
Stopcock	155	16	0%	90.2%
ICU Medical	110	55	0.3%	97.2%
Medex	34	8	0%	81.7%
Clearlink/Continu-Flo	14	331	0.1%	96.9%
Baxter	6	3	3.8%	54.2%
Blood Administration Set	5	0	0.5%	99.5%
Clearlink	5	136	0%	99.1%
ChemoClave Vented Bag Spike	3	42	0%	100%
BD Syringe	2	117	0.4%	94.6%
MicroClave Clear Neutral Connector	2	76	0.4%	97.3%
Spinning Spiros Closed Male Luer, Red Cap	2	63	0%	99.1%
Alaris Pump Module Administration Set	1	0	0.2%	94.6%
Braun	1	24	0.5%	71.8%
Q-Syte	1	209	0%	98%
Tego Connector	1	212	0.3%	94.7%

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
Icu Medical De Mexico S De R L De C V	2,592	43.1%
Bd Infusion Therapy Systems De C V	1,022	17%
Icu Medical	328	5.5%
Medex	226	3.8%
Baxter Healthcare - Aibonito	221	3.7%
Smiths Medical Asd	98	1.6%
Baxter Healthcare - Malta	94	1.6%
Baxter Healthcare - Cleveland	81	1.3%
Baxter Healthcare	69	1.1%
Becton Dickinson	46	0.8%
Bd Suzhou Mds	38	0.6%
Baxter Healthcare - Cali	36	0.6%
Bd	35	0.6%
B Braun Melsungen	26	0.4%
Smiths Medical	25	0.4%

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

Death0.4%25

Injury6%363

Malfunction92.7%5,571

Other0.4%25

Not given0.4%25

Who filed

Manufacturer report92.3%5,544

Voluntary report2%119

User facility report0%0

Distributor report0.1%8

Not given5.6%338

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	2,273	37.8%
Leak/splashthe device leaked	1,018	16.9%
Crackthe device cracked	607	10.1%
Disconnection	547	9.1%
Breakthe device broke	320	5.3%
No flow	310	5.2%
Material separation	231	3.8%
Device contamination with chemical or other material	158	2.6%
Connection problema connection problem	131	2.2%
Air/gas in device	121	2%
Loose or intermittent connection	99	1.6%
Detachment of device component	78	1.3%
Particulates	76	1.3%
Detachment of device or device componentpart of the device came off	70	1.2%
Infusion or flow problema problem with flow or infusion	62	1%
Separation problem	60	1%
Backflow	59	1%
Replace	48	0.8%
Contamination	41	0.7%
Defective component	40	0.7%

Questions about stopcock, i.v. set reports

What is product code FMG?

FDA's classification code for "Stopcock, i.v. set", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

6,009 reports through August 2026, 874 of them in the latest 12 months.

Which brands appear most often?

Bd Connecta Stopcock (288), Access (222), Stopcock (155), ICU Medical (110) and Medex (34). 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.