Devices › Saline, vascular access flush
Device brand name · Saline vascular access flush
Syringe 10ml Reg Pr Saline 10ml Fill: medical device reports filed with FDA
156 reports name it, 2019–2025. Manufacturer given most often on reports: Bd Medical Bd West Medical Surgical. Product code NGT.
- 156
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 0
- reports, 12 months to August 2026
- 19 in the 12 months before
- 98.7%
- classified as malfunction
- 88% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 156 reports that name the brand "Syringe 10ml Reg Pr Saline 10ml Fill" (saline vascular access flush), received between January 2019 and July 2025; the manufacturer given most often on reports is Bd Medical Bd West Medical Surgical. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 19 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 (98.7%), injury (0.6%) and other (0.6%); across all saline, vascular access flush reports (product code NGT) death is recorded in 0.7% and malfunction in 88%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to deliver (48.7%), leak/splash (41.7%) and device contamination with chemical or other material (6.4%). The patient problems coded most often are no patient involvement and exposure to body fluids. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,171 reports carrying product code NGT. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Failure to deliverthe device did not deliver the dose or item | 76 | 48.7% | 12.1% |
| Leak/splashthe device leaked | 65 | 41.7% | 26.8% |
| Device contamination with chemical or other material | 10 | 6.4% | 6.1% |
| Defective component | 7 | 4.5% | 2.6% |
| Device markings/labelling problema problem with the device markings or label | 7 | 4.5% | 4.3% |
| Breakthe device broke | 5 | 3.2% | 8.3% |
| Material separation | 5 | 3.2% | 2.2% |
| Physical resistance/sticking | 4 | 2.6% | 3.9% |
| Contamination | 2 | 1.3% | 2.5% |
| Contamination /decontamination problem | 2 | 1.3% | 0.8% |
| Material deformation | 2 | 1.3% | 1.2% |
| Complete blockage | 1 | 0.6% | 0.4% |
| Component missing | 1 | 0.6% | 1% |
| Defective devicethe device was defective | 1 | 0.6% | 0.9% |
| Dent in material | 1 | 0.6% | 0% |
| Difficult to flush | 1 | 0.6% | 0.4% |
| Improper flow or infusion | 1 | 0.6% | 0% |
| Inability to irrigate | 1 | 0.6% | 0.1% |
| Inadequacy of device shape and/or size | 1 | 0.6% | 0% |
| Labelling, instructions for use or training problem | 1 | 0.6% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 3 | 1.9% |
| Exposure to body fluids | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Syringe 10ml Reg Pr Saline 10ml Fill | Product code NGT | All MAUDE reports |
|---|---|---|---|
| Reports | 156 | 3,171 | 26,136,888 |
| Share of that pool | — | 4.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 7 | 9 |
| Classified as injury | 0.6% | 8.8% | 36.2% |
| Classified as malfunction | 98.7% | 88% | 62.3% |
| Filed by the manufacturer | 99.4% | 89.4% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code NGT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bd Posiflush Normal Saline Syringe | 529 | 0 | 0% |
| 10 Ml Bd Posiflush Normal Saline Syringe | 253 | 0 | 0% |
| Bd Posiflush Syringe | 187 | 0 | 0.5% |
| Syringe 10ml Saline Fill China Sp | 162 | 21 | 0% |
| Syringe 5ml Saline Fill China Sp | 177 | 23 | 0% |
| Monoject | 430 | 14 | 0.2% |
| B Braun | 270 | 12 | 3% |
| Unknown Prefill | 184 | 0 | 53.8% |
| Bd | 191 | 0 | 1% |
| Unspecified Bd Syringe | 926 | 0 | 0.1% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Syringe 10ml Reg Pr Saline 10ml Fill reports
How many FDA reports name Syringe 10ml Reg Pr Saline 10ml Fill?
156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (98.7%), injury (0.6%) and other (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to deliver (48.7%), leak/splash (41.7%), device contamination with chemical or other material (6.4%), defective component (4.5%) and device markings/labelling problem (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Syringe 10ml Reg Pr Saline 10ml Fill was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.