Closed antineoplastic and hazardous drug reconstitution and transfer system: medical device reports filed with FDA

4,837 reports carry this product code, 2012–2026; 9 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.

4,837
reports with this product code: 0% of all MAUDE reports; 783
reports, 12 months to August 2026: 939 in the 12 months before; 96.4%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code ONB is FDA's classification for "Closed antineoplastic and hazardous drug reconstitution and transfer system" (general Hospital panel), a class 2 device. 4,837 medical device reports carry this product code, 0% of the MAUDE database, from December 2012 to August 2026.

783 reports arrived in the 12 months to August 2026, down 17% from 939 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 (96.4%), injury (3.1%) and other (0.3%). 9 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
ChemoClave Vented Bag Spike	150	42	0%	100%
Spinning Spiros Closed Male Luer, Red Cap	99	63	0%	99.1%
ICU Medical	12	55	0.3%	97.2%
Unspecified BD Infusion Set	3	484	0.2%	99%
Cadd Legacy Pump	2	4	0.2%	91.6%
Administration Set	1	2	1.4%	86.9%
Alaris	1	79	1.1%	85.8%
BD alaris pump infusion set	1	55	1.1%	92.2%
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
Becton Dickinson	2,817	58.2%
Icu Medical De Mexico S De R L De C V	1,440	29.8%
Icu Medical	170	3.5%
Sistemas Medicos Alaris De C V	21	0.4%
Bd	6	0.1%
Bd Infusion Therapy Systems De C V	6	0.1%
Becton Dickinson Infusion Therapy Systems	5	0.1%
Bd Suzhou Mds	2	0%
Icu Medical Costa Rica	2	0%
Bd Medical - Diabetes Care	1	0%
Becton Dickinson And	1	0%
Becton Dickinson And Bd Biosciences	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

Death0%0

Injury3.1%151

Malfunction96.4%4,661

Other0.3%16

Not given0.2%9

Who filed

Manufacturer report88.9%4,300

Voluntary report7.9%382

User facility report0%0

Distributor report0%0

Not given3.2%155

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

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	1,440	29.8%
Fluid/blood leak	1,131	23.4%
Disconnection	398	8.2%
Device contamination with chemical or other material	384	7.9%
Breakthe device broke	245	5.1%
Contamination	144	3%
Material separation	142	2.9%
No flow	126	2.6%
Infusion or flow problema problem with flow or infusion	113	2.3%
Particulates	110	2.3%
Detachment of device or device componentpart of the device came off	81	1.7%
Defective component	76	1.6%
Defective devicethe device was defective	69	1.4%
Loose or intermittent connection	62	1.3%
Air/gas in device	61	1.3%
Connection problema connection problem	57	1.2%
Difficult or delayed activation	50	1%
Crackthe device cracked	49	1%
Separation problem	38	0.8%
Contamination /decontamination problem	33	0.7%

Questions about closed antineoplastic and hazardous drug reconstitution and transfer system reports

What is product code ONB?

FDA's classification code for "Closed antineoplastic and hazardous drug reconstitution and transfer system", 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?

4,837 reports through August 2026, 783 of them in the latest 12 months.

Which brands appear most often?

ChemoClave Vented Bag Spike (150), Spinning Spiros Closed Male Luer, Red Cap (99), ICU Medical (12), Unspecified BD Infusion Set (3) and Cadd Legacy Pump (2). 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.