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2026 data FDA MAUDE openFDA FDA Class I

Infusor, Pressure, For I.V. Bags

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 §880.5420 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Infusor, Pressure, For I.V. Bags LIGHT-BOOK · MAUDE

#883 of 1000 · 508 reports · 1992–2026

  • BOOK 508 reports
  • RANK #883 of 1000
  • DEATH 15 death-typed
  • INJ 42 injury-typed
  • MALF 432 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 72
  • PHOTO Laparoscopic Accessor…

Nearest event-volume peer: Laparoscopic Accessories, Gynecologic (0 report gap)

Infusor, Pressure, For I.V. Bags sits #883 of 1000 among tracked device types with 508 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 →

Injury-coded reports sit below the device-type norm

Infusor, Pressure, For I.V. Bags carries 8.3% INJURY-coded reports, 22.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.0% corpus 1.5% · above corpus mean (+1.4 pp)
  • INJ 8.3% corpus 30.3% · below corpus mean (-22.0 pp)
  • MALF 85.0% corpus 64.8% · above corpus mean (+20.2 pp)

Lead product-problem code Air Leak is 22% of coded problems · Lead manufacturer MERIT MEDICAL SYSTEMS, INC. accounts for 39% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .

Infusor, Pressure, For I.V. Bags in the event-volume neighbourhood

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

reports

What this shows Infusor, Pressure, For I.V. Bags carries 508 MAUDE reports, ranked #883 of 1000.

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

Event Types

Malfunction 432 (85.0%)
Injury 42 (8.3%)
Other 16 (3.1%)
Death 15 (3.0%)
3 (0.6%)

Patient Outcomes

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

352 (68.0%)
Other 110 (21.2%)
Required Intervention 28 (5.4%)
Death 12 (2.3%)
R 8 (1.5%)
Life Threatening 4 (0.8%)
L 1 (0.2%)
O 1 (0.2%)
Disability 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

Air Leak 118
Loss of or Failure to Bond 93
Leak/Splash 61
Gas/Air Leak 36
Decrease in Pressure 29
Inflation Problem 28
Pressure Problem 24
Material Split, Cut or Torn 17
Excess Flow or Over-Infusion 16
Material Integrity Problem 14
Device Contamination with Chemical or Other Material 13
Pressure, insufficient 13
Use of Device Problem 13
Replace 12
Device Issue 11
Crack 10
Detachment Of Device Component 10
Break 8
Disconnection 8
Unintended Deflation 8

Yearly Trend

92
1992: 2
93
1993: 3
96
1996: 5
97
1997: 5
98
1998: 1
99
1999: 2
00
2000: 16
01
2001: 25
02
2002: 7
03
2003: 30
04
2004: 20
05
2005: 4
06
2006: 9
08
2008: 3
09
2009: 6
10
2010: 9
11
2011: 12
12
2012: 1
14
2014: 72
15
2015: 31
16
2016: 4
17
2017: 38
18
2018: 6
19
2019: 4
20
2020: 8
21
2021: 13
22
2022: 45
23
2023: 31
24
2024: 43
25
2025: 41
26
2026: 12

Reports in 2025 (41) held close to the prior two-year average of 37.

Related Entities for Infusor, Pressure, For I.V. Bags

Top Manufacturers

MERIT MEDICAL SYSTEMS, INC. 112
SMITHS MEDICAL ASD, INC. 108
ABBOTT LABORATORIES 42
VYAIRE MEDICAL 15
ICU MEDICAL, INC. 7

Event Locations

376 (74.0%)
HOSPITAL 67 (13.2%)
I 52 (10.2%)
INVALID DATA 8 (1.6%)
NO INFORMATION 3 (0.6%)
NOT APPLICABLE 1 (0.2%)
OTHER 1 (0.2%)

Compare MERIT MEDICAL SYSTEMS, INC. vs SMITHS MEDICAL ASD, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Infusor, Pressure, For I.V. Bags: 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 (508 here).

Laparoscopic Accessories, Gynecologic 508 Cutter, Wire 510 Stylet, Tracheal Tube 506 Tubing, Pressure And Accessories 510

Similar death-typed counts

Nearest other device types by death-typed report count (15 here), distinct from the volume row.

Catheter 15 Display, Cathode-Ray Tube, Medical 15 Endoscopic Tissue Approximation Device 15 Guide, Wire, Catheter, Neurovasculature 15

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

Disclaimer: MAUDE figures for Infusor, Pressure, For I.V. Bags 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 Infusor, Pressure, For I.V. Bags; 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.