Container, i.v.: medical device reports filed with FDA

6,773 reports carry this product code, 1992–2026; 16 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.

6,773
reports with this product code: 0% of all MAUDE reports; 265
reports, 12 months to August 2026: 217 in the 12 months before; 96.6%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code KPE is FDA's classification for "Container, i.v." (general Hospital panel), a class 2 device. 6,773 medical device reports carry this product code, 0% of the MAUDE database, from March 1992 to August 2026.

265 reports arrived in the 12 months to August 2026, up 22% from 217 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 (96.6%), injury (1.3%) and other (0.6%). 16 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
Ivt Disposable	3,234	0	0%	99.7%
Intravia Container Empty	656	0	0%	100%
Exactamix Eva Bag	655	0	0%	99.5%
All-In-One Container	235	0	0%	100%
Apex	231	78	1.3%	86.8%
Intravia	193	92	0%	100%
Pinnacle	41	499	0.1%	75%
Walkmed	36	0	0%	95.8%
Exactamix	30	811	0%	99.7%
B Braun	9	12	3%	77.8%
Baxter	5	3	3.8%	54.2%
Ni	4	1,587	1.8%	29.5%
Braun	2	24	0.5%	71.8%
Vial-Mate Reconstitution Device	2	0	0%	100%
250 Ml Tpn Bag	1	0	0%	100%
Extension Set	1	66	1.3%	56.6%

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
Baxter Healthcare - Aibonito	2,202	32.5%
Baxter Healthcare	1,162	17.2%
Baxter Healthcare - Malta	822	12.1%
Baxter Healthcare - Cali	344	5.1%
Hospira	126	1.9%
Baxter Healthcare - Cleveland	78	1.2%
B Braun Medical	61	0.9%
Icu Medical Costa Rica	53	0.8%
Baxter International	40	0.6%
Abbott Laboratories	33	0.5%
Hospira Costa Rica	4	0.1%
Abbott	3	0%
Baxter Healthcare Round Lake	3	0%
C R Bard	2	0%
Becton Dickinson	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

Death0.1%8

Injury1.3%85

Malfunction96.6%6,544

Other0.6%38

Not given1.4%98

Who filed

Manufacturer report86.6%5,865

Voluntary report9.8%665

User facility report0%0

Distributor report0.1%7

Not given3.5%236

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device contamination with chemical or other material	2,605	38.5%
Fluid/blood leak	1,381	20.4%
Leak/splashthe device leaked	604	8.9%
Particulates	431	6.4%
Contamination /decontamination problem	331	4.9%
Breakthe device broke	156	2.3%
Hole in material	147	2.2%
Disconnection	102	1.5%
Material separation	92	1.4%
Foreign material	81	1.2%
Defective devicethe device was defective	69	1%
Detachment of device or device componentpart of the device came off	60	0.9%
Detachment of device component	53	0.8%
Misassembled	53	0.8%
Crackthe device cracked	44	0.6%
Device operates differently than expectedthe device behaved unexpectedly	44	0.6%
Tears, rips, holes in device, device material	44	0.6%
Failure to disconnect	42	0.6%
Suction problem	35	0.5%
Contamination	34	0.5%

Questions about container, i.v. reports

What is product code KPE?

FDA's classification code for "Container, i.v.", 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?

6,773 reports through August 2026, 265 of them in the latest 12 months.

Which brands appear most often?

Ivt Disposable (3,234), Intravia Container Empty (656), Exactamix Eva Bag (655), All-In-One Container (235) and Apex (231). 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.