Catheter, intravascular, therapeutic, short-term less than 30 days: medical device reports filed with FDA

49,301 reports carry this product code, 1992–2026; 30 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.

49,301
reports with this product code: 0.2% of all MAUDE reports; 4,629
reports, 12 months to August 2026: 5,344 in the 12 months before; 83.5%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code FOZ is FDA's classification for "Catheter, intravascular, therapeutic, short-term less than 30 days" (general Hospital panel), a class 2 device. 49,301 medical device reports carry this product code, 0.2% of the MAUDE database, from February 1992 to August 2026.

4,629 reports arrived in the 12 months to August 2026, down 13% from 5,344 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 (83.5%), injury (13.1%) and other (2.6%). 30 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
Insyte AUTOGUARD	1,306	1,050	0%	95.4%
BD Insyte Autoguard	1,238	55	0%	93.7%
Introcan Safety	964	45	0.1%	68%
Bd Insyte Autog Bc	695	0	0%	98%
Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm	665	123	0.1%	98.1%
Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm	663	170	0.1%	98.4%
Nexiva	383	304	0%	97.1%
Mahurkar	368	6	1.1%	92.4%
BD Nexiva	367	14	0%	94.6%
Jelco	267	34	0%	84.3%
Arrow Pi Cvc Kit 3-L 7 Fr X 20 Cm Agb	265	63	1%	95.1%
Arrow Cvc Set 16 Ga X 8 20 Cm	258	0	0%	99.8%
Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm	232	12	0%	98.2%
Bd Nexiva Single Port	224	0	0%	99.6%
Unspecified Bd Catheter	220	0	0%	78.5%
Accu-Chek Tender Infusion Set	218	0	0%	66.5%
First Picc	180	0	0.4%	72.8%
First Picc S/L 26ga 1 9f 0 65mm X 50cm	174	13	0%	87.8%
Arrow Cvc Set 3-Lumen 7fr X 20cm	170	30	0.4%	96.3%
Bd Insyte Autog Bc Wing	163	15	0%	99.4%
Cook Spectrum	160	0	0%	71.3%
Bd Insyte	150	0	0%	97.3%
Interlink Injection Site	139	0	0%	92%
Vaxcel Picc	137	0	0%	82.2%
I-Port Advance	132	191	0%	87.5%
Cvc Set 3-Lumen 7 Fr X 20 Cm	131	0	0%	95.4%
Interlink Catheter Extension Set	128	0	1.1%	97.2%
Cvc Set 2-Lumen 7 Fr X 20 Cm	127	0	0.4%	96.7%
Arrow	69	65	3.4%	66.7%
L-Cath PICC S/L 26ga (1.9F) 0.60mm x 30cm	67	33	0%	86.1%

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 Infusion Therapy Systems	12,296	24.9%
Arrow International	5,666	11.5%
Becton Dickinson	3,435	7%
Bd Suzhou	3,008	6.1%
Becton Dickinson Medical Singapore	2,801	5.7%
Bd Suzhou Mds	1,702	3.5%
Bd Infusion Therapy Systems De C V	1,620	3.3%
Becton Dickinson Industrias Cirurgicas Ltda	1,604	3.3%
C R Bard Basd -3006260740	1,292	2.6%
Smiths Medical Asd	1,243	2.5%
Bard Access Systems	1,060	2.2%
Cook	873	1.8%
Argon Medical Devices	860	1.7%
B Braun Melsungen	830	1.7%
Becton Dickinson And	751	1.5%

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

Death0.3%141

Injury13.1%6,464

Malfunction83.5%41,159

Other2.6%1,302

Not given0.5%235

Who filed

Manufacturer report89.6%44,184

Voluntary report4.7%2,303

User facility report0%0

Distributor report0.3%147

Not given5.4%2,667

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

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	10,565	21.4%
Breakthe device broke	5,377	10.9%
Retraction problem	4,450	9%
Fluid/blood leak	3,296	6.7%
Device contamination with chemical or other material	2,896	5.9%
Material separation	2,072	4.2%
Defective component	1,261	2.6%
Material puncture/hole	1,111	2.3%
Crackthe device cracked	1,040	2.1%
Material deformation	974	2%
Difficult to removethe device was hard to remove	892	1.8%
Material twisted/bent	846	1.7%
Deformation due to compressive stress	840	1.7%
Unraveled material	828	1.7%
Detachment of device component	783	1.6%
Kinkedthe tube or line kinked	752	1.5%
Material split, cut or torn	717	1.5%
Material protrusion/extrusion	683	1.4%
Detachment of device or device componentpart of the device came off	628	1.3%
Difficult to insertthe device was hard to insert	608	1.2%

Questions about catheter, intravascular, therapeutic, short-term less than 30 days reports

What is product code FOZ?

FDA's classification code for "Catheter, intravascular, therapeutic, short-term less than 30 days", 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?

49,301 reports through August 2026, 4,629 of them in the latest 12 months.

Which brands appear most often?

Insyte AUTOGUARD (1,306), BD Insyte Autoguard (1,238), Introcan Safety (964), Bd Insyte Autog Bc (695) and Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm (665). 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.