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2026 data FDA MAUDE openFDA FDA Class II

Saline, Vascular Access Flush

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 §880.5200 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Saline, Vascular Access Flush LIGHT-BOOK · MAUDE

#395 of 1000 · 3,148 reports · 1996–2026

  • BOOK 3,148 reports
  • RANK #395 of 1000
  • DEATH 22 death-typed
  • INJ 270 injury-typed
  • MALF 2,780 malfunction
  • SPAN 1996–2026
  • PEAK 2021: 566
  • PHOTO Dressing, Wound, Drug

Nearest event-volume peer: Dressing, Wound, Drug (4 report gap)

Saline, Vascular Access Flush sits #395 of 1000 among tracked device types with 3,148 MAUDE reports spanning 1996–2026. 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

Saline, Vascular Access Flush carries 88.3% MALFUNCTION-coded reports, 23.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 8.6% corpus 30.3% · below corpus mean (-21.7 pp)
  • MALF 88.3% corpus 64.8% · above corpus mean (+23.5 pp)

Lead product-problem code Leak/Splash is 30% of coded problems · Lead manufacturer BD MEDICAL (BD WEST) MEDICAL SURGICAL accounts for 58% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Saline, Vascular Access Flush in the event-volume neighbourhood

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

reports

What this shows Saline, Vascular Access Flush carries 3,148 MAUDE reports, ranked #395 of 1000.

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

Event Types

Malfunction 2,780 (88.3%)
Injury 270 (8.6%)
Other 61 (1.9%)
Death 22 (0.7%)
15 (0.5%)

Patient Outcomes

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

1,891 (59.5%)
Other 1,050 (33.1%)
Hospitalization 86 (2.7%)
Required Intervention 75 (2.4%)
Death 19 (0.6%)
R 11 (0.3%)
O 10 (0.3%)
Life Threatening 10 (0.3%)
L 8 (0.3%)
H 7 (0.2%)
Disability 5 (0.2%)
S 4 (0.1%)
D 1 (0.0%)

Top Product Problems

Leak/Splash 848
Failure to Deliver 385
Break 263
Device Contamination with Chemical or Other Material 189
Device Markings/Labelling Problem 136
Physical Resistance/Sticking 123
Packaging Problem 115
Adverse Event Without Identified Device or Use Problem 85
Defective Component 81
Contamination 79
Material Separation 70
Crack 66
Microbial Contamination of Device 66
Fluid/Blood Leak 61
Nonstandard Device 50
Material Discolored 46
Appropriate Device Problem Term/Code Not Available 43
Short Fill 42
Insufficient Device Problem Information 41
Device Damaged Prior to Use 40

Yearly Trend

96
1996: 1
04
2004: 1
05
2005: 3
06
2006: 1
07
2007: 31
08
2008: 64
09
2009: 18
10
2010: 23
11
2011: 20
12
2012: 5
13
2013: 25
14
2014: 25
15
2015: 14
16
2016: 82
17
2017: 56
18
2018: 270
19
2019: 340
20
2020: 322
21
2021: 566
22
2022: 282
23
2023: 313
24
2024: 332
25
2025: 216
26
2026: 138

Reports in 2025 (216) held close to the prior two-year average of 323.

Related Entities for Saline, Vascular Access Flush

Top Manufacturers

BD MEDICAL (BD WEST) MEDICAL SURGICAL 1,453
BECTON, DICKINSON AND CO. 413
BECTON DICKINSON 394
BECTON DICKINSON, S.A. 160
COVIDIEN 73

Event Locations

1,529 (48.6%)
I 1,451 (46.1%)
NO INFORMATION 94 (3.0%)
HOSPITAL 58 (1.8%)
OUTPATIENT TREATMENT FACILITY 6 (0.2%)
OTHER 5 (0.2%)
HOME 4 (0.1%)
UNKNOWN 1 (0.0%)

Compare BD MEDICAL (BD WEST) MEDICAL SURGICAL vs BECTON, DICKINSON AND CO. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Saline, Vascular Access Flush: 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 (3,148 here).

Dressing, Wound, Drug 3,144 Endoscopic Tissue Approximation Device 3,154 Culture Media, Enriched 3,141 Dilator 3,156

Similar death-typed counts

Nearest other device types by death-typed report count (22 here), distinct from the volume row.

Accessories, Cleaning, For Endoscope 22 Charger, Pacemaker 22 Device, Thermal Ablation, Endometrial 22 Endoscopic Access Overtube 22

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Saline, Vascular Access Flush 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 Saline, Vascular Access Flush; 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.