What are FDA adverse event reports for Introducer, Syringe Needle?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Introducer, Syringe Needle, there are 1,076 total reports including 1 death reports and 237 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Introducer, Syringe Needle?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Introducer, Syringe Needle

Name: Introducer, Syringe Needle - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Introducer, Syringe Needle LIGHT-BOOK · MAUDE

#639 of 1000 · 1,076 reports · 1992–2026

BOOK 1,076 reports
RANK #639 of 1000
DEATH 1 death-typed
INJ 237 injury-typed
MALF 827 malfunction
SPAN 1992–2026
PEAK 2020: 158
PHOTO Laryngoscope

Nearest event-volume peer: Laryngoscope, Non-Rigid (2 report gap)

Introducer, Syringe Needle sits #639 of 1000 among tracked device types with 1,076 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
INJ 22.0% corpus 30.4% · below corpus mean (-8.4 pp)
MALF 76.9% corpus 64.5% · above corpus mean (+12.4 pp)

Lead product-problem code Unintended Ejection is 45% 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 .

Instrument

1,086
Apparatus

1,081
Automated Uri…

1,080
Introducer (this)

1,076
Laryngoscope

1,074
System

1,072

What this shows Introducer, Syringe Needle carries 1,076 MAUDE reports, ranked #639 of 1000.

Event Types

Malfunction 827 (76.9%)

Injury 237 (22.0%)

Other 6 (0.6%)

5 (0.5%)

Death 1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

917 (84.1%)

Hospitalization 86 (7.9%)

Other 44 (4.0%)

Required Intervention 24 (2.2%)

R 9 (0.8%)

S 3 (0.3%)

H 2 (0.2%)

Life Threatening 2 (0.2%)

Death 1 (0.1%)

Disability 1 (0.1%)

Invalid Data 1 (0.1%)

Yearly Trend

1992: 2

1993: 2

1994: 4

1995: 2

1999: 1

2000: 1

2001: 1

2002: 3

2003: 1

2005: 1

2007: 2

2010: 3

2011: 20

2012: 20

2013: 53

2014: 138

2015: 99

2016: 68

2017: 88

2018: 88

2019: 95

2020: 158

2021: 87

2022: 58

2023: 35

2024: 27

2025: 17

2026: 2

Top Manufacturers

ROCHE DIABETES CARE, INC. 482

MEDTRONIC MINIMED 212

ROCHE DIAGNOSTICS 46

UNK 14

Event Locations

I 396 (36.8%)

353 (32.8%)

NO INFORMATION 162 (15.1%)

HOME 57 (5.3%)

U 56 (5.2%)

OTHER 23 (2.1%)

HOSPITAL 21 (2.0%)

INVALID DATA 4 (0.4%)

OUTPATIENT TREATMENT FACILITY 3 (0.3%)

NOT APPLICABLE 1 (0.1%)

Compare ROCHE DIABETES CARE, INC. vs MEDTRONIC MINIMED →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Introducer, Syringe Needle, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,076 here).

Laryngoscope, Non-Rigid 1,074 Automated Urinalysis System 1,080 System, Dialysate Delivery, Single Patient 1,072 Apparatus, Suction, Patient Care 1,081

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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.

Introducer, Syringe Needle

Event-type mix vs corpus