Saline, vascular access flush: medical device reports filed with FDA

3,171 reports carry this product code, 1996–2026; 11 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.

3,171
reports with this product code: 0% of all MAUDE reports; 222
reports, 12 months to August 2026: 243 in the 12 months before; 88%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

Product code NGT is FDA's classification for "Saline, vascular access flush" (general Hospital panel), a class 2 device. 3,171 medical device reports carry this product code, 0% of the MAUDE database, from June 1996 to August 2026.

222 reports arrived in the 12 months to August 2026, close to the 243 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 (88%), injury (8.8%) and other (2%). 11 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 Posiflush Normal Saline Syringe	495	0	0%	97.9%
10 Ml Bd Posiflush Normal Saline Syringe	213	0	0%	99.2%
Bd Posiflush Syringe	155	0	0.5%	98.9%
Syringe 10ml Saline Fill China Sp	119	21	0%	99.4%
Syringe 5ml Saline Fill China Sp	108	23	0%	100%
Syringe 10ml Reg Pr Saline 10ml Fill	100	0	0%	98.7%
Monoject	11	14	0.2%	88.4%
B Braun	6	12	3%	77.8%
Unknown Prefill	4	0	53.8%	39.7%
Bd	1	0	1%	56%
Unspecified Bd Syringe	1	0	0.1%	94.1%

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
Bd Medical Bd West Medical Surgical	1,459	46%
Becton Dickinson And	510	16.1%
Becton Dickinson	339	10.7%
Bd	51	1.6%
B Braun Medical	41	1.3%
Sistemas Medicos Alaris De C V	8	0.3%
Hospira	6	0.2%
Becton Dickinson Infusion Therapy Systems	3	0.1%
Becton Dickinson Medical Systems	3	0.1%
Becton Dickinson De Mexico	2	0.1%
Abbott	1	0%
Bard Access Systems	1	0%
Bd Suzhou	1	0%
Becton Dickinson & Bd	1	0%
Becton Dickinson & Broken Bow	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

Death0.7%23

Injury8.8%278

Malfunction88%2,792

Other2%62

Not given0.5%16

Who filed

Manufacturer report89.4%2,835

Voluntary report8.5%270

User facility report0%0

Distributor report0%0

Not given2.1%66

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

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	850	26.8%
Failure to deliverthe device did not deliver the dose or item	385	12.1%
Breakthe device broke	264	8.3%
Device contamination with chemical or other material	192	6.1%
Device markings/labelling problema problem with the device markings or label	135	4.3%
Physical resistance/sticking	123	3.9%
Packaging problem	116	3.7%
Defective component	81	2.6%
Contamination	80	2.5%
Material separation	70	2.2%
Crackthe device cracked	66	2.1%
Microbial contamination of device	66	2.1%
Fluid/blood leak	59	1.9%
Nonstandard device	47	1.5%
Material discolored	40	1.3%
Volume accuracy problem	40	1.3%
Short fill	39	1.2%
Device damaged prior to usethe device was damaged before use	37	1.2%
Insufficient device problem information	37	1.2%
Material deformation	37	1.2%

Questions about saline, vascular access flush reports

What is product code NGT?

FDA's classification code for "Saline, vascular access flush", 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?

3,171 reports through August 2026, 222 of them in the latest 12 months.

Which brands appear most often?

Bd Posiflush Normal Saline Syringe (495), 10 Ml Bd Posiflush Normal Saline Syringe (213), Bd Posiflush Syringe (155), Syringe 10ml Saline Fill China Sp (119) and Syringe 5ml Saline Fill China Sp (108). 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.