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2026 data FDA MAUDE openFDA FDA Class I

Device, Intravascular Catheter Securement

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 §880.5210 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Device, Intravascular Catheter Securement LIGHT-BOOK · MAUDE

#761 of 1000 · 749 reports · 1998–2026

  • BOOK 749 reports
  • RANK #761 of 1000
  • DEATH 3 death-typed
  • INJ 82 injury-typed
  • MALF 643 malfunction
  • SPAN 1998–2026
  • PEAK 2023: 138
  • PHOTO Osteotome

Nearest event-volume peer: Osteotome (0 report gap)

Device, Intravascular Catheter Securement sits #761 of 1000 among tracked device types with 749 MAUDE reports spanning 1998–2026. 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

Device, Intravascular Catheter Securement carries 85.8% MALFUNCTION-coded reports, 21.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 10.9% corpus 30.3% · below corpus mean (-19.3 pp)
  • MALF 85.8% corpus 64.8% · above corpus mean (+21.0 pp)

Lead product-problem code Detachment of Device or Device Component is 32% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 78% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Device, Intravascular Catheter Securement in the event-volume neighbourhood

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

reports

What this shows Device, Intravascular Catheter Securement carries 749 MAUDE reports, ranked #761 of 1000.

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

Event Types

Malfunction 643 (85.8%)
Injury 82 (10.9%)
Other 18 (2.4%)
3 (0.4%)
Death 3 (0.4%)

Patient Outcomes

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

Other 438 (58.0%)
251 (33.2%)
Required Intervention 49 (6.5%)
R 6 (0.8%)
Hospitalization 5 (0.7%)
Death 3 (0.4%)
O 1 (0.1%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Detachment of Device or Device Component 198
Loss of or Failure to Bond 89
Misconnection 67
Adverse Event Without Identified Device or Use Problem 44
Defective Component 28
Difficult to Remove 26
Break 20
Disconnection 17
Device Dislodged or Dislocated 14
Leak/Splash 14
Material Separation 14
Detachment Of Device Component 12
Device Operates Differently Than Expected 12
Device Disinfection Or Sterilization Issue 11
Failure To Adhere Or Bond 11
Improper or Incorrect Procedure or Method 11
Delivered as Unsterile Product 10
Unknown (for use when the device problem is not known) 10
Fluid/Blood Leak 9
Difficult or Delayed Positioning 8

Yearly Trend

98
1998: 1
99
1999: 3
01
2001: 2
02
2002: 9
03
2003: 10
04
2004: 1
05
2005: 9
06
2006: 2
07
2007: 1
08
2008: 7
09
2009: 3
10
2010: 5
11
2011: 2
12
2012: 1
13
2013: 4
14
2014: 18
15
2015: 41
16
2016: 19
17
2017: 45
18
2018: 40
19
2019: 10
20
2020: 14
21
2021: 33
22
2022: 103
23
2023: 138
24
2024: 104
25
2025: 75
26
2026: 49

Reports fell to 75 in 2025, down from an average of 121 in the two years before.

Related Entities for Device, Intravascular Catheter Securement

Top Manufacturers

C.R. BARD, INC. (BASD) -3006260740 370
BARD ACCESS SYSTEMS 75
C.R. BARD, INC. (COVINGTON) -1018233 16
BECTON DICKINSON 11

Event Locations

565 (75.4%)
HOSPITAL 77 (10.3%)
I 75 (10.0%)
NO INFORMATION 14 (1.9%)
HOME 8 (1.1%)
OUTPATIENT TREATMENT FACILITY 4 (0.5%)
OTHER 3 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
NURSING HOME 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare C.R. BARD, INC. (BASD) -3006260740 vs BARD ACCESS SYSTEMS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Intravascular Catheter Securement: 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 (749 here).

Osteotome 749 Catheter, Balloon Type 751 Extractor, Vacuum, Fetal 751 Implanted Brain Stimulator For Epilepsy 746

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 Device, Intravascular Catheter Securement 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 Device, Intravascular Catheter Securement; 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.