Needle, hypodermic, single lumen: medical device reports filed with FDA

39,876 reports carry this product code, 1993–2026; 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.

39,876
reports with this product code: 0.2% of all MAUDE reports; 1,747
reports, 12 months to August 2026: 3,337 in the 12 months before; 87.6%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code FMI is FDA's classification for "Needle, hypodermic, single lumen" (general Hospital panel), a class 2 device. 39,876 medical device reports carry this product code, 0.2% of the MAUDE database, from July 1993 to August 2026.

1,747 reports arrived in the 12 months to August 2026, down 48% from 3,337 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 (87.6%), injury (10.5%) and other (1.4%). 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
Unspecified Bd Pen Needle	1,781	0	0.1%	94.7%
BD Vacutainer Eclipse Blood Collection Needle	1,535	627	0%	91%
Bd Safetyglide Needle	1,253	3	0%	98.5%
Bd Precisionglide Needle	1,202	0	0%	95.9%
Bd Nano 2nd Gen Pen Needle	783	0	0%	98.5%
Bd Ultra Fine Pen Needles	650	0	0%	95.3%
Pen Ndl 32g 4mm Pro 100 Box 1200 Us	508	9	0%	99.8%
BD SafetyGlide	500	127	0%	98.4%
Ez-Io Power Driver	454	0	2.2%	96.3%
BD Vacutainer Eclipse Blood Collection Needle with Pre-Attached Holder	415	18	0%	92.7%
Bd Ultra Fine Pen Needle	366	0	0%	94.1%
Bd Safetyglide Needle Only 25 G	328	0	0%	99.1%
Unspecified Bd Needle	319	0	0%	88.1%
Bd Ultra-Fine Pen Needle	309	0	0%	95%
Magellan	298	20	0%	95.2%
Bd Vacutainer Flashback Blood Collection Needle	297	0	0%	98.3%
Bd Eclipse Needle	296	1	0%	88.6%
Bd Ultra-Fine Nano Pen Needles 4mm 5/32 32g	236	0	0%	95%
Pen Ndl 32g 4mm Pro 14 Bag 700 Case Jpx	230	19	0%	94%
Pen Ndl 32g 4mm Hp 100 Box 1200 Us	217	0	0%	96.4%
Pen Needles FG	210	43	0%	94.8%
Bd Autoshield Duo Safety Pen Needle	200	0	0%	85.1%
Needle 30x1/2 Rb	198	0	0%	98%
BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder	194	124	0%	98%
Pen Ndl 32g 4mm 100bx 1200 Usa	190	10	0%	96.4%
Bd Nano 2nd Gen Pen Needles 32g X 4mm 100 Count	185	0	0%	99.5%
Bd Micro-Fine Pro Pen Needle	177	0	0%	98.3%
Bd Autoshield Duo Pen Needle	160	0	0%	88.3%
McKesson Brands	157	75	0%	83.1%
Bd Micro-Fine + Pen Needle	156	0	0%	93.6%

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
Becton Dickinson And	8,525	21.4%
Becton Dickinson	7,446	18.7%
Becton Dickinson Medical Systems	2,758	6.9%
Becton Dickinson & Bd	2,420	6.1%
Bd Medical Bd West Medical Surgical	2,096	5.3%
Embecta Penel - Dun Laoghaire Ireland	1,367	3.4%
Becton Dickinson Medical Singapore	1,300	3.3%
Covidien	946	2.4%
Smiths Medical Asd	829	2.1%
Becton Dickinson Ind Cirurgicas Ltda	826	2.1%
Teleflex Medical	807	2%
Becton Dickinson And Bd	590	1.5%
Bd	545	1.4%
Bd Medical - Diabetes Care	426	1.1%
Cardinal Health	316	0.8%

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

Death0.2%68

Injury10.5%4,190

Malfunction87.6%34,948

Other1.4%543

Not given0.3%127

Who filed

Manufacturer report92.1%36,734

Voluntary report5.1%2,051

User facility report0%0

Distributor report0.7%287

Not given2%804

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to deliverthe device did not deliver the dose or item	6,967	17.5%
Breakthe device broke	5,053	12.7%
Complete blockage	3,399	8.5%
Leak/splashthe device leaked	3,398	8.5%
Device contamination with chemical or other material	2,139	5.4%
Fluid/blood leak	1,304	3.3%
Detachment of device component	1,201	3%
Defective devicethe device was defective	1,137	2.9%
Misconnection	1,122	2.8%
Detachment of device or device componentpart of the device came off	1,057	2.7%
Device markings/labelling problema problem with the device markings or label	866	2.2%
Difficult or delayed activation	855	2.1%
Defective component	619	1.6%
Product quality problem	542	1.4%
Material protrusion/extrusion	536	1.3%
Material twisted/bent	524	1.3%
Packaging problem	493	1.2%
Material separation	470	1.2%
Difficult to removethe device was hard to remove	469	1.2%
Component missing	456	1.1%

Questions about needle, hypodermic, single lumen reports

What is product code FMI?

FDA's classification code for "Needle, hypodermic, single lumen", 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?

39,876 reports through August 2026, 1,747 of them in the latest 12 months.

Which brands appear most often?

Unspecified Bd Pen Needle (1,781), BD Vacutainer Eclipse Blood Collection Needle (1,535), Bd Safetyglide Needle (1,253), Bd Precisionglide Needle (1,202) and Bd Nano 2nd Gen Pen Needle (783). 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.