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2026 data FDA MAUDE openFDA FDA Class I

Syringe, Irrigating (Non Dental)

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §880.6960 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Syringe, Irrigating LIGHT-BOOK · MAUDE

#837 of 1000 · 586 reports · 1994–2026

  • BOOK 586 reports
  • RANK #837 of 1000
  • DEATH 1 death-typed
  • INJ 48 injury-typed
  • MALF 526 malfunction
  • SPAN 1994–2026
  • PEAK 2024: 106
  • PHOTO Chair

Nearest event-volume peer: Chair, Adjustable, Mechanical (0 report gap)

Syringe, Irrigating (Non Dental) sits #837 of 1000 among tracked device types with 586 MAUDE reports spanning 1994–2026. 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

Syringe, Irrigating carries 89.8% MALFUNCTION-coded reports, 24.9pp 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 8.2% corpus 30.3% · below corpus mean (-22.1 pp)
  • MALF 89.8% corpus 64.8% · above corpus mean (+24.9 pp)

Lead product-problem code Device Contamination with Chemical or Other Material is 35% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 55% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .

Syringe, Irrigating in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Syringe, Irrigating (Non Dental) carries 586 MAUDE reports, ranked #837 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 526 (89.8%)
Injury 48 (8.2%)
Other 8 (1.4%)
3 (0.5%)
Death 1 (0.2%)

Patient Outcomes

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

355 (60.2%)
Other 193 (32.7%)
Required Intervention 26 (4.4%)
Hospitalization 6 (1.0%)
Disability 3 (0.5%)
L 2 (0.3%)
O 2 (0.3%)
D 1 (0.2%)
R 1 (0.2%)
S 1 (0.2%)

Top Product Problems

Device Contamination with Chemical or Other Material 182
Break 47
Contamination /Decontamination Problem 40
Leak/Splash 37
Contamination 33
Appropriate Device Problem Term/Code Not Available 22
Suction Problem 22
Device Markings/Labelling Problem 18
Fluid/Blood Leak 18
Detachment Of Device Component 17
Mechanical Problem 13
Detachment of Device or Device Component 12
Device Damaged Prior to Use 10
Physical Resistance/Sticking 10
Decrease in Suction 9
Disconnection 9
Material Fragmentation 7
Material Separation 7
Packaging Problem 7
Expiration Date Error 6

Yearly Trend

94
1994: 1
95
1995: 1
96
1996: 6
97
1997: 3
98
1998: 2
99
1999: 1
00
2000: 1
01
2001: 7
02
2002: 6
03
2003: 1
04
2004: 2
05
2005: 1
06
2006: 3
08
2008: 4
09
2009: 3
10
2010: 2
11
2011: 4
12
2012: 1
13
2013: 12
14
2014: 10
15
2015: 11
16
2016: 8
17
2017: 52
18
2018: 76
19
2019: 69
20
2020: 88
21
2021: 41
22
2022: 11
23
2023: 14
24
2024: 106
25
2025: 28
26
2026: 11

Reports fell to 28 in 2025, down from an average of 60 in the two years before.

Related Entities for Syringe, Irrigating (Non Dental)

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 220
MEDLINE INDUSTRIES, LP 84
BD MEDICAL (BD WEST) MEDICAL SURGICAL 57
MEDLINE INDUSTRIES LP 19
BECTON DICKINSON 17

Event Locations

I 299 (51.0%)
216 (36.9%)
HOSPITAL 52 (8.9%)
NO INFORMATION 11 (1.9%)
HOME 3 (0.5%)
OTHER 2 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
INVALID DATA 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs MEDLINE INDUSTRIES, LP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Syringe, Irrigating: 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 (586 here).

Chair, Adjustable, Mechanical 586 Mesh, Surgical, Absorbable, Abdominal Hernia 586 Mouthguard, Prescription 584 Calibrator, Multi-Analyte Mixture 582

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 Syringe, Irrigating 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 Syringe, Irrigating; 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.