Syringe, piston: medical device reports filed with FDA

53,081 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.

53,081
reports with this product code: 0.2% of all MAUDE reports; 4,159
reports, 12 months to August 2026: 4,309 in the 12 months before; 88.5%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code FMF is FDA's classification for "Syringe, piston" (general Hospital panel), a class 2 device. 53,081 medical device reports carry this product code, 0.2% of the MAUDE database, from July 1992 to August 2026.

4,159 reports arrived in the 12 months to August 2026, close to the 4,309 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 (88.5%), injury (9.9%) and other (0.8%). 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
Inpen Mmt-105nnblna Novo Nordisk Blue	1,620	188	0.1%	93.5%
Inpen Mmt-105elblna Eli Lily Blue	1,292	168	0.1%	95.3%
Inpen Mmt-105nnpkna Novo Nordisk Pink	1,142	219	0.1%	92.6%
Rsvr Mmt-326a 10pk Prdgm 1 8ml 13l	1,034	0	0.4%	95.5%
Kit MMT-105NNBLW1 NovoNordisk Blue OUS1	1,011	655	0%	99.4%
BD Luer-Lok	999	333	0%	98.6%
Inpen Mmt-105nngyna Novo Nordisk Gray	972	143	0%	95.1%
Unspecified Bd Syringe	900	0	0.1%	94.1%
Bd Insulin Syringe With The Bd Ultra-Fine Needle	848	0	0%	97.5%
Bd Ultra-Fine Insulin Syringe	812	0	0%	98.9%
Inpen Mmt-105elpkna Eli Lily Pink	805	123	0%	93.9%
Inpen Mmt-105elgyna Eli Lily Gray	736	88	0%	94.8%
Bd Luer-Lok Tip Syringe	624	0	0%	99.8%
Bd Luer-Lok Syringe	593	0	0%	99.5%
Novopen 4	560	67	0.7%	3.2%
Rsvr Mmt-332a 10pk Prdgm 3cc 14l	493	0	0.7%	91.1%
Relion Insulin Syringe	474	0	0%	95.7%
Syringe 50ml Ll	472	23	0%	98.5%
BD Syringe	453	117	0.4%	94.6%
Bd Syringe Luer-Lok Tip	443	0	0%	98.7%
Kit MMT-105ELGYW1 Eli Lilly Grey OUS1	422	270	0%	91%
Bd Plastipak Luer-Lok Syringe	415	0	0%	99.3%
Bd Plastipak Concentric Luer Lock Syringe	410	0	0.2%	98.6%
Bd Plastipak Syringe	405	25	0%	99%
Rsvr Prdgm	382	0	0%	96.3%
Bd Insulin Syringe With Bd Ultra-Fine Needle	363	0	0%	97.1%
Luer-Lok	353	256	0%	99.4%
Bd Luer-Lok Disposable Syringe With Bd Luer-Lok Tip	322	0	0%	99.7%
Monoject	277	14	0.2%	88.4%
EasyTouch	253	42	0%	96.8%

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	9,574	18%
Companion Medical	8,162	15.4%
Bd Medical - Diabetes Care	7,274	13.7%
Becton Dickinson Medical Systems	6,179	11.6%
Bd Medical Bd West Medical Surgical	2,466	4.6%
Medtronic Minimed	1,780	3.4%
Becton Dickinson Ind Cirurgicas Ltda	1,681	3.2%
Eli Lilly And	1,557	2.9%
Becton Dickinson De Mexico	1,084	2%
Novo Nordisk A/S Medical Systems	1,009	1.9%
Becton Dickinson Medical Singapore	951	1.8%
Covidien	870	1.6%
Becton Dickinson And	778	1.5%
Medtronic Puerto Rico Operations Med-Rel	566	1.1%
Bd Infusion Therapy Systems De C V	499	0.9%

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%66

Injury9.9%5,269

Malfunction88.5%46,977

Other0.8%436

Not given0.6%333

Who filed

Manufacturer report93.7%49,760

Voluntary report4.6%2,455

User facility report0%0

Distributor report0.4%211

Not given1.2%655

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

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	9,553	18%
Device contamination with chemical or other material	6,383	12%
Breakthe device broke	4,875	9.2%
Fluid/blood leak	3,208	6%
Patient device interaction problem	2,984	5.6%
Device markings/labelling problema problem with the device markings or label	2,097	4%
Failure to deliverthe device did not deliver the dose or item	1,905	3.6%
Volume accuracy problem	1,863	3.5%
Computer software problema software problem	1,431	2.7%
Contamination	1,405	2.6%
Crackthe device cracked	1,371	2.6%
Defective component	1,182	2.2%
Physical resistance/sticking	1,083	2%
Defective devicethe device was defective	924	1.7%
Material too rigid or stiff	915	1.7%
Packaging problem	889	1.7%
Contamination /decontamination problem	864	1.6%
Material integrity problema problem with the device material	734	1.4%
Detachment of device or device componentpart of the device came off	630	1.2%
Data problem	625	1.2%

Questions about syringe, piston reports

What is product code FMF?

FDA's classification code for "Syringe, piston", 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?

53,081 reports through August 2026, 4,159 of them in the latest 12 months.

Which brands appear most often?

Inpen Mmt-105nnblna Novo Nordisk Blue (1,620), Inpen Mmt-105elblna Eli Lily Blue (1,292), Inpen Mmt-105nnpkna Novo Nordisk Pink (1,142), Rsvr Mmt-326a 10pk Prdgm 1 8ml 13l (1,034) and Kit MMT-105NNBLW1 NovoNordisk Blue OUS1 (1,011). 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.