Needle, aspiration and injection, disposable: medical device reports filed with FDA

1,806 reports carry this product code, 1992–2026; 10 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.

1,806
reports with this product code: 0% of all MAUDE reports; 172
reports, 12 months to August 2026: 383 in the 12 months before; 78.7%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code GAA is FDA's classification for "Needle, aspiration and injection, disposable" (general, Plastic Surgery panel), a class 1 device. 1,806 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

172 reports arrived in the 12 months to August 2026, down 55% from 383 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 (78.7%), injury (18.8%) and other (1.7%). 10 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
Needle Filter Blunt Fill 18x1-1/2	254	49	0%	70.7%
Needle 18x1-1/2 Blunt Fill	179	18	0%	99.4%
Bd Blunt Fill Needle	138	1	0%	96.8%
Single Use Aspiration Needle	15	144	0.4%	79.4%
Monoject	7	14	0.2%	88.4%
Superdimension	3	5	7%	12.3%
Olympus	2	9	2.5%	69.7%
Cardinal Health	1	185	0.2%	89.8%
Depuy	1	9	1.8%	27.9%
Single Use Injector	1	40	0%	95.5%

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	594	32.9%
Becton Dickinson	402	22.3%
Becton Dickinson And	64	3.5%
Angiomed & Medizintechnik Kg	21	1.2%
Cook Endoscopy	19	1.1%
Becton Dickinson Ind Cirurgicas Ltda	17	0.9%
Covidien - Superdimension	17	0.9%
Argon Medical Devices	10	0.6%
Becton Dickinson De Mexico	10	0.6%
Depuy Synthes Spine	9	0.5%
Alphatec Spine	5	0.3%
Horizon Medical Products	5	0.3%
Terumo Medical	5	0.3%
C R Bard	4	0.2%
Carefusion	4	0.2%

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%1

Injury18.8%340

Malfunction78.7%1,422

Other1.7%30

Not given0.7%13

Who filed

Manufacturer report89%1,608

Voluntary report6.4%115

User facility report0%0

Distributor report0.8%14

Not given3.8%69

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device contamination with chemical or other material	365	20.2%
Breakthe device broke	287	15.9%
Defective component	228	12.6%
Contamination	82	4.5%
Leak/splashthe device leaked	64	3.5%
Contamination /decontamination problem	60	3.3%
Detachment of device component	53	2.9%
Complete blockage	32	1.8%
Packaging problem	32	1.8%
Device, or device fragments remain in patient	30	1.7%
Dull, blunt	26	1.4%
Difficult to removethe device was hard to remove	23	1.3%
Fracturea broken bone	21	1.2%
Tip breakage	21	1.2%
Device operates differently than expectedthe device behaved unexpectedly	20	1.1%
Bent	19	1.1%
Detachment of device or device componentpart of the device came off	19	1.1%
Entrapment of device	19	1.1%
Replace	19	1.1%
Device, removal of (non-implant)	18	1%

Questions about needle, aspiration and injection, disposable reports

What is product code GAA?

FDA's classification code for "Needle, aspiration and injection, disposable", class 1, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,806 reports through August 2026, 172 of them in the latest 12 months.

Which brands appear most often?

Needle Filter Blunt Fill 18x1-1/2 (254), Needle 18x1-1/2 Blunt Fill (179), Bd Blunt Fill Needle (138), Single Use Aspiration Needle (15) and Monoject (7). 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.