Introducer, Syringe Needle
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 §880.6920 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Introducer, Syringe Needle LIGHT-BOOK · MAUDE
#646 of 1000 · 1,079 reports · 1992–2026
- BOOK 1,079 reports
- RANK #646 of 1000
- DEATH 1 death-typed
- INJ 238 injury-typed
- MALF 829 malfunction
- SPAN 1992–2026
- PEAK 2020: 158
- PHOTO Hemostatic Device For…
Nearest event-volume peer: Hemostatic Device For Endoscopic Gastrointestinal Use (2 report gap)
Introducer, Syringe Needle sits #646 of 1000 among tracked device types with 1,079 MAUDE reports spanning 1992–2026. 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
Introducer, Syringe Needle carries 76.8% MALFUNCTION-coded reports, 12.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 22.1% corpus 30.3% · below corpus mean (-8.2 pp)
- MALF 76.8% corpus 64.8% · above corpus mean (+12.0 pp)
Lead product-problem code Unintended Ejection is 35% of coded problems · Lead manufacturer ROCHE DIABETES CARE, INC. accounts for 64% of manufacturer-tagged reports · Top event location I is 37% of location-tagged rows .
Introducer, Syringe Needle in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Instrument
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
1,087 reports
- Automated Uri…
Automated Urinalysis System
1,086 reports
- Introducer (this)
Introducer, Syringe Needle
1,079 reports
- Hemostatic De…
Hemostatic Device For Endoscopic Gastrointestinal Use
1,077 reports
- System
System, Dialysate Delivery, Single Patient
1,072 reports
- Occluder
Occluder, Patent Ductus, Arteriosus
1,071 reports
What this shows Introducer, Syringe Needle carries 1,079 MAUDE reports, ranked #646 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 17 in 2025, down from an average of 31 in the two years before.
Related Entities for Introducer, Syringe Needle
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Introducer, Syringe Needle: 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 (1,079 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Introducer, Syringe Needle 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 Introducer, Syringe Needle; 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.