2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Port & Catheter MID-BOOK · MAUDE

#134 of 1000 · 20,085 reports · 1992–2026

  • BOOK 20,085 reports
  • RANK #134 of 1000
  • DEATH 293 death-typed
  • INJ 11,206 injury-typed
  • MALF 8,156 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 4,363
  • PHOTO Reagents

Nearest event-volume peer: Reagents, 2019-Novel Coronavirus Nucleic Acid (50 report gap)

Port & Catheter, Implanted, Subcutaneous, Intravascular sits #134 of 1000 among tracked device types with 20,085 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 1.5% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 55.8% corpus 30.4% · above corpus mean (+25.4 pp)
  • MALF 40.6% corpus 64.5% · below corpus mean (-23.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 21% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 73% of manufacturer-tagged reports · Top event location is 58% 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 20,085 MAUDE reports, ranked #134 of 1000.

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

Event Types

Injury 11,206 (55.8%)
Malfunction 8,156 (40.6%)
Death 293 (1.5%)
Other 277 (1.4%)
153 (0.8%)

Patient Outcomes

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

Required Intervention 8,704 (39.8%)
6,926 (31.7%)
Other 2,464 (11.3%)
R 981 (4.5%)
Hospitalization 881 (4.0%)
Life Threatening 667 (3.1%)
Death 298 (1.4%)
O 292 (1.3%)
L 240 (1.1%)
H 175 (0.8%)
Disability 126 (0.6%)
S 56 (0.3%)
D 25 (0.1%)
Invalid Data 12 (0.1%)
Congenital Anomaly 4 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 3,919
Fracture 3,919
Fluid/Blood Leak 1,616
Material Separation 1,410
Deformation Due to Compressive Stress 1,134
Migration 1,018
Suction Problem 887
Difficult to Flush 627
Obstruction of Flow 617
Naturally Worn 577
Break 550
Detachment of Device or Device Component 392
Difficult to Remove 316
Stretched 236
Defective Component 228
Component Missing 213
Expulsion 207
Disconnection 206
Failure to Advance 199
Material Protrusion/Extrusion 182

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: 532

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

Event Locations

11,643 (58.0%)
I 3,670 (18.3%)
HOSPITAL 3,649 (18.2%)
NO INFORMATION 203 (1.0%)
INVALID DATA 193 (1.0%)
UNKNOWN 179 (0.9%)
HOME 145 (0.7%)
OTHER 140 (0.7%)
OUTPATIENT TREATMENT FACILITY 126 (0.6%)
AMBULATORY SURGICAL FACILITY 75 (0.4%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Port & Catheter, 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 (20,085 here).

Similar death-typed counts

Nearest other device types by death-typed report count (293 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.