Set, tubing, blood, with and without anti-regurgitation valve: medical device reports filed with FDA

8,114 reports carry this product code, 1992–2026; 13 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.

8,114
reports with this product code: 0% of all MAUDE reports; 2,038
reports, 12 months to August 2026: 853 in the 12 months before; 75.7%
classified as malfunction: 62.3% across all reports; 3.8%
classified as death, as reported: 0.9% across all reports

Product code FJK is FDA's classification for "Set, tubing, blood, with and without anti-regurgitation valve" (gastroenterology, Urology panel), a class 2 device. 8,114 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

2,038 reports arrived in the 12 months to August 2026, up 139% from 853 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 (75.7%), injury (18.5%) and death (3.8%). 13 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
Hemodialysis Bloodlines	2,566	1,135	0.4%	99.4%
Custom Combi Set	750	15	3.8%	87.1%
Combiset Bloodline	741	677	0%	98.8%
Combi Set	282	0	3.4%	93.2%
Medisystems Hemodialysis Blood Tubing Set	278	0	5.7%	20.6%
Cartridge	191	0	3%	59.1%
Fresenius	16	0	6.1%	13.7%
Liberty Cycler Set Single Conn /Ext Dl	4	952	0.5%	68.1%
Cobe Centrysystem 3	2	0	0.8%	83.3%
Dialyzer	1	69	2.2%	57.4%
Fusa F80b Hf/Ps/1 8/H	1	0	0%	13.7%
Phoenix	1	16	5.5%	32.9%
Prismaflex	1	4	7.7%	56.9%

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
B Braun Medical	2,450	30.2%
Erika De Reynosa De C V	1,753	21.6%
Reynosa Manufacturing	464	5.7%
Fresenius Medical Care North America	241	3%
Gambro Healthcare	109	1.3%
Fresenius USA	44	0.5%
Baxter Healthcare - Cali	36	0.4%
Allegiance Healthcare	26	0.3%
Baxter Healthcare	16	0.2%
Vantive US Healthcare	14	0.2%
Nxstage Medical	8	0.1%
Medcomp	6	0.1%
Icu Medical De Mexico S De R L De C V	5	0.1%
Icu Medical	2	0%
Arrow International	1	0%

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

Death3.8%307

Injury18.5%1,504

Malfunction75.7%6,142

Other1.5%125

Not given0.4%36

Who filed

Manufacturer report87.8%7,128

Voluntary report4%322

User facility report0%0

Distributor report2.5%199

Not given5.7%465

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	1,826	22.5%
Air/gas in device	1,782	22%
Leak/splashthe device leaked	1,327	16.4%
Incomplete or inadequate connection	509	6.3%
Replace	348	4.3%
Kinkedthe tube or line kinked	340	4.2%
Detachment of device or device componentpart of the device came off	303	3.7%
Material separation	296	3.6%
Disconnection	262	3.2%
Material puncture/hole	211	2.6%
Crackthe device cracked	198	2.4%
Air leak	181	2.2%
Device alarm system	115	1.4%
Loose or intermittent connection	115	1.4%
Breakthe device broke	87	1.1%
Insufficient device problem information	76	0.9%
Obstruction of flow	76	0.9%
Other (for use when an appropriate device code cannot be identified)	64	0.8%
Tears, rips, holes in device, device material	64	0.8%
Detachment of device component	56	0.7%

Questions about set, tubing, blood, with and without anti-regurgitation valve reports

What is product code FJK?

FDA's classification code for "Set, tubing, blood, with and without anti-regurgitation valve", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

8,114 reports through August 2026, 2,038 of them in the latest 12 months.

Which brands appear most often?

Hemodialysis Bloodlines (2,566), Custom Combi Set (750), Combiset Bloodline (741), Combi Set (282) and Medisystems Hemodialysis Blood Tubing Set (278). 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.