2026 data FDA MAUDE openFDA FDA Class II

Port & Catheter, Implanted, Subcutaneous, Intravascular

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 §880.5965 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Port & Catheter MID-BOOK · MAUDE

#135 of 1000 · 21,943 reports · 1992–2026

  • BOOK 21,943 reports
  • RANK #135 of 1000
  • DEATH 373 death-typed
  • INJ 12,591 injury-typed
  • MALF 8,549 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 4,363
  • PHOTO Lens

Nearest event-volume peer: Lens, Intraocular, Phakic (54 report gap)

Port & Catheter, Implanted, Subcutaneous, Intravascular sits #135 of 1000 among tracked device types with 21,943 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 run above the device-type norm

Port & Catheter carries 57.4% INJURY-coded reports, 27.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 57.4% corpus 30.3% · above corpus mean (+27.1 pp)
  • MALF 39.0% corpus 64.8% · below corpus mean (-25.9 pp)

Lead product-problem code Fracture is 18% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 79% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Port & Catheter in the event-volume neighbourhood

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

reports

What this shows Port & Catheter, Implanted, Subcutaneous, Intravascular carries 21,943 MAUDE reports, ranked #135 of 1000.

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

Event Types

Injury 12,591 (57.4%)
Malfunction 8,549 (39.0%)
Death 373 (1.7%)
Other 277 (1.3%)
153 (0.7%)

Patient Outcomes

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

Required Intervention 9,848 (41.3%)
7,331 (30.7%)
Other 2,500 (10.5%)
R 1,055 (4.4%)
Hospitalization 912 (3.8%)
Life Threatening 704 (2.9%)
Death 366 (1.5%)
O 365 (1.5%)
L 311 (1.3%)
H 252 (1.1%)
Disability 126 (0.5%)
S 57 (0.2%)
D 27 (0.1%)
Invalid Data 12 (0.1%)
Congenital Anomaly 4 (0.0%)

Top Product Problems

Fracture 5,197
Adverse Event Without Identified Device or Use Problem 4,764
Fluid/Blood Leak 1,989
Material Separation 1,965
Explanted 1,940
Break 1,906
Deformation Due to Compressive Stress 1,257
Migration or Expulsion of Device 1,216
Migration 1,193
Suction Problem 987
Obstruction of Flow 773
Difficult to Flush 764
Leak/Splash 750
Replace 723
Difficult to Remove 645
Naturally Worn 631
Component(s), broken 508
Implant, removal of 476
Device Appears to Trigger Rejection 474
Detachment of Device or Device Component 441

Yearly Trend

92
1992: 21
93
1993: 41
94
1994: 151
95
1995: 175
96
1996: 470
97
1997: 1,090
98
1998: 430
99
1999: 354
00
2000: 439
01
2001: 345
02
2002: 331
03
2003: 241
04
2004: 293
05
2005: 303
06
2006: 235
07
2007: 208
08
2008: 161
09
2009: 172
10
2010: 207
11
2011: 202
12
2012: 153
13
2013: 141
14
2014: 143
15
2015: 149
16
2016: 135
17
2017: 262
18
2018: 878
19
2019: 765
20
2020: 959
21
2021: 1,285
22
2022: 1,334
23
2023: 1,221
24
2024: 1,896
25
2025: 4,363
26
2026: 2,390

Reports rose to 4,363 in 2025, up from an average of 1,559 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Port & Catheter, Implanted, Subcutaneous, Intravascular

Event Locations

13,495 (61.5%)
I 3,670 (16.7%)
HOSPITAL 3,654 (16.7%)
NO INFORMATION 203 (0.9%)
INVALID DATA 193 (0.9%)
UNKNOWN 179 (0.8%)
HOME 145 (0.7%)
OTHER 140 (0.6%)
OUTPATIENT TREATMENT FACILITY 127 (0.6%)
AMBULATORY SURGICAL FACILITY 75 (0.3%)
NOT APPLICABLE 43 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 11 (0.1%)
NURSING HOME 3 (0.0%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
EMERGENCY ROOM 1 (0.0%)
OPERATING ROOM 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

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 Port & Catheter: 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 (21,943 here).

Similar death-typed counts

Nearest other device types by death-typed report count (373 here), distinct from the volume row.

Disclaimer: MAUDE figures for Port & Catheter 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 Port & Catheter; 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.