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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#871 of 1000 · 501 reports · 1992–2026

  • BOOK 501 reports
  • RANK #871 of 1000
  • DEATH 15 death-typed
  • INJ 42 injury-typed
  • MALF 425 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 72
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Traction, Non-Powered (1 report gap)

Infusor, Pressure, For I.V. Bags sits #871 of 1000 among tracked device types with 501 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 3.0% corpus 1.5% · above corpus mean (+1.5 pp)
  • INJ 8.4% corpus 30.4% · below corpus mean (-22.1 pp)
  • MALF 84.8% corpus 64.5% · above corpus mean (+20.3 pp)

Lead product-problem code Leak/Splash is 20% 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 501 MAUDE reports, ranked #871 of 1000.

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

Event Types

Malfunction 425 (84.8%)
Injury 42 (8.4%)
Other 16 (3.2%)
Death 15 (3.0%)
3 (0.6%)

Patient Outcomes

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

350 (68.4%)
Other 106 (20.7%)
Required Intervention 28 (5.5%)
Death 12 (2.3%)
R 8 (1.6%)
Life Threatening 4 (0.8%)
L 1 (0.2%)
O 1 (0.2%)
Disability 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

Leak/Splash 51
Gas/Air Leak 33
Pressure Problem 21
Decrease in Pressure 18
Inflation Problem 17
Material Split, Cut or Torn 17
Material Integrity Problem 14
Device Contamination with Chemical or Other Material 12
Crack 9
Air Leak 8
Disconnection 8
Unintended Deflation 8
Fluid/Blood Leak 6
Appropriate Term/Code Not Available 5
Device Markings/Labelling Problem 5
Mechanical Problem 5
Break 4
Defective Device 4
Detachment of Device or Device Component 4
Device Operates Differently Than Expected 4

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: 5

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

369 (73.7%)
HOSPITAL 67 (13.4%)
I 52 (10.4%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Infusor, Pressure, For I.V. Bags, 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 (501 here).

Apparatus, Traction, Non-Powered 502 Bronchial Thermoplasty System 500 Laparoscopic Accessories, Gynecologic 502 Bone Grafting Material, Synthetic 499

Similar death-typed counts

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

Catheter 15 Guide, Wire, Catheter, Neurovasculature 15 Posterior Cervical Screw System 15 Prosthesis, Rib Replacement 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.