Needle, Hypodermic, Single Lumen
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5570 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Needle, Hypodermic, Single Lumen MID-BOOK · MAUDE
#86 of 1000 · 39,692 reports · 1993–2026
- BOOK 39,692 reports
- RANK #86 of 1000
- DEATH 67 death-typed
- INJ 4,168 injury-typed
- MALF 34,790 malfunction
- SPAN 1993–2026
- PEAK 2023: 4,986
- PHOTO Plate, Fixation, Bone
Nearest event-volume peer: Plate, Fixation, Bone (874 report gap)
Needle, Hypodermic, Single Lumen sits #86 of 1000 among tracked device types with 39,692 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Needle, Hypodermic, Single Lumen carries 87.6% MALFUNCTION-coded reports, 22.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 10.5% corpus 30.3% · below corpus mean (-19.8 pp)
- MALF 87.6% corpus 64.8% · above corpus mean (+22.8 pp)
Lead product-problem code Failure to Deliver is 21% of coded problems · Lead manufacturer BECTON DICKINSON AND CO. accounts for 31% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .
Needle, Hypodermic, Single Lumen in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Introducer
Introducer, Catheter
40,656 reports
- Needle (this)
Needle, Hypodermic, Single Lumen
39,692 reports
- Plate
Plate, Fixation, Bone
38,818 reports
- Mesh
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
38,646 reports
- Device
Device, Impotence, Mechanical/Hydraulic
38,353 reports
- Filter
Filter, Intravascular, Cardiovascular
38,320 reports
What this shows Needle, Hypodermic, Single Lumen carries 39,692 MAUDE reports, ranked #86 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 2,465 in 2025, down from an average of 4,520 in the two years before.
Related Entities for Needle, Hypodermic, Single Lumen
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Needle, Hypodermic, Single Lumen: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (39,692 here).
Similar death-typed counts
Nearest other device types by death-typed report count (67 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Needle, Hypodermic, Single Lumen are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Needle, Hypodermic, Single Lumen; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.