What are FDA adverse event reports for Filter, Infusion Line?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Filter, Infusion Line, there are 1,167 total reports including 3 death reports and 89 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Filter, Infusion Line?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Filter, Infusion Line

Name: Filter, Infusion Line - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5440 (General Hospital panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Filter, Infusion Line LIGHT-BOOK · MAUDE

#631 of 1000 · 1,167 reports · 1993–2026

BOOK 1,167 reports
RANK #631 of 1000
DEATH 3 death-typed
INJ 89 injury-typed
MALF 1,039 malfunction
SPAN 1993–2026
PEAK 2021: 160
PHOTO Agent

Nearest event-volume peer: Agent, Tooth Bonding, Resin (8 report gap)

Filter, Infusion Line sits #631 of 1000 among tracked device types with 1,167 MAUDE reports spanning 1993–2026. 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

Filter, Infusion Line carries 89.0% MALFUNCTION-coded reports, 24.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
INJ 7.6% corpus 30.3% · below corpus mean (-22.7 pp)
MALF 89.0% corpus 64.8% · above corpus mean (+24.2 pp)

Lead product-problem code Fluid/Blood Leak is 41% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 48% of manufacturer-tagged reports · Top event location is 36% of location-tagged rows .

Endovascular…

1,181
Spinal Pedicl…

1,178
Holder

1,177
Filter (this)

1,167
Agent

1,159
Agent

1,158

What this shows Filter, Infusion Line carries 1,167 MAUDE reports, ranked #631 of 1000.

Event Types

Malfunction 1,039 (89.0%)

Injury 89 (7.6%)

Other 21 (1.8%)

15 (1.3%)

Death 3 (0.3%)

Patient Outcomes

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

988 (83.7%)

Other 93 (7.9%)

Required Intervention 64 (5.4%)

Hospitalization 13 (1.1%)

R 10 (0.8%)

Life Threatening 6 (0.5%)

Death 3 (0.3%)

L 1 (0.1%)

O 1 (0.1%)

Disability 1 (0.1%)

Yearly Trend

1993: 2

1994: 13

1995: 13

1996: 12

1997: 17

1998: 13

1999: 25

2000: 37

2001: 61

2002: 20

2003: 32

2004: 14

2005: 23

2006: 14

2007: 14

2008: 44

2009: 33

2010: 32

2011: 20

2012: 21

2013: 44

2014: 68

2015: 25

2016: 95

2017: 53

2018: 35

2019: 31

2020: 18

2021: 160

2022: 36

2023: 39

2024: 47

2025: 34

2026: 22

Reports in 2025 (34) held close to the prior two-year average of 43.

Top Manufacturers

BAXTER HEALTHCARE CORPORATION 240

CAREFUSION 104

SMITHS MEDICAL ASD, INC. 95

BAXTER HEALTHCARE - AIBONITO 56

Event Locations

416 (35.6%)

I 378 (32.4%)

HOSPITAL 314 (26.9%)

HOME 21 (1.8%)

NO INFORMATION 14 (1.2%)

UNKNOWN 11 (0.9%)

OTHER 5 (0.4%)

INVALID DATA 4 (0.3%)

OUTPATIENT TREATMENT FACILITY 3 (0.3%)

NURSING HOME 1 (0.1%)

Compare BAXTER HEALTHCARE CORPORATION vs CAREFUSION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Filter, Infusion Line: 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 (1,167 here).

Agent, Tooth Bonding, Resin 1,159 Agent 1,158 Holder, Ureteral Catheter 1,177 Spinal Pedicle Screw 1,178

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Filter, Infusion Line 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 Filter, Infusion Line; 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.

Filter, Infusion Line

Malfunction reports run above the device-type norm