2026 data FDA MAUDE openFDA FDA Class II

Heparin, 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).

FDA MAUDE casebook

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

#733 of 1000 · 800 reports · 2004–2026

  • BOOK 800 reports
  • RANK #733 of 1000
  • DEATH 206 death-typed
  • INJ 234 injury-typed
  • MALF 280 malfunction
  • SPAN 2004–2026
  • PEAK 2008: 291
  • PHOTO Tray

Nearest event-volume peer: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) (0 report gap)

Heparin, Vascular Access Flush sits #733 of 1000 among tracked device types with 800 MAUDE reports spanning 2004–2026. 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 sit below the device-type norm

Heparin, Vascular Access Flush carries 35.0% MALFUNCTION-coded reports, 29.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 25.8% corpus 1.5% · above corpus mean (+24.2 pp)
  • INJ 29.3% corpus 30.3% · below corpus mean (-1.0 pp)
  • MALF 35.0% corpus 64.8% · below corpus mean (-29.8 pp)

Lead product-problem code Other (for use when an appropriate device code cannot be identified) is 32% of coded problems · Lead manufacturer COVIDIEN accounts for 85% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Heparin, Vascular Access Flush in the event-volume neighbourhood

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

reports

What this shows Heparin, Vascular Access Flush carries 800 MAUDE reports, ranked #733 of 1000.

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

Event Types

Malfunction 280 (35.0%)
Injury 234 (29.3%)
Death 206 (25.8%)
Other 66 (8.3%)
14 (1.8%)

Patient Outcomes

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

273 (29.7%)
Death 208 (22.7%)
Other 141 (15.4%)
Hospitalization 108 (11.8%)
O 38 (4.1%)
Required Intervention 34 (3.7%)
R 29 (3.2%)
L 24 (2.6%)
Life Threatening 23 (2.5%)
S 14 (1.5%)
H 13 (1.4%)
Disability 13 (1.4%)

Top Product Problems

Other (for use when an appropriate device code cannot be identified) 260
Unknown (for use when the device problem is not known) 162
Nonstandard Device 97
Contamination of Device Ingredient or Reagent 66
Microbial Contamination of Device 36
Device Markings/Labelling Problem 31
Insufficient Device Problem Information 31
Contamination 23
Replace 22
Manufacturing, Packaging or Shipping Problem 12
Adverse Event Without Identified Device or Use Problem 10
Device Operates Differently Than Expected 10
Patient-Device Incompatibility 8
Infusion or Flow Problem 7
Packaging Problem 6
Break 5
Device Emits Odor 5
Leak/Splash 5
Off-Label Use 5
Short Fill 5

Yearly Trend

04
2004: 2
06
2006: 1
07
2007: 21
08
2008: 291
09
2009: 122
10
2010: 194
11
2011: 33
12
2012: 9
13
2013: 15
14
2014: 8
15
2015: 5
17
2017: 3
18
2018: 19
19
2019: 19
20
2020: 3
21
2021: 10
22
2022: 14
23
2023: 9
24
2024: 10
25
2025: 11
26
2026: 1

Reports in 2025 (11) held close to the prior two-year average of 10.

Related Entities for Heparin, Vascular Access Flush

Event Locations

382 (47.8%)
HOSPITAL 190 (23.8%)
OTHER 95 (11.9%)
HOME 45 (5.6%)
I 41 (5.1%)
NO INFORMATION 20 (2.5%)
OUTPATIENT TREATMENT FACILITY 19 (2.4%)
UNKNOWN 7 (0.9%)
INVALID DATA 1 (0.1%)

Compare COVIDIEN vs BD MEDICAL (BD WEST) MEDICAL SURGICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Heparin, 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 (800 here).

Similar death-typed counts

Nearest other device types by death-typed report count (206 here), distinct from the volume row.

Disclaimer: MAUDE figures for Heparin, 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 Heparin, 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.