2026 data FDA MAUDE openFDA FDA Class II

Catheter, Peritoneal, Long-Term Indwelling

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 §876.5630 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Catheter, Peritoneal, Long-Term Indwelling LIGHT-BOOK · MAUDE

#461 of 1000 · 2,355 reports · 1994–2026

  • BOOK 2,355 reports
  • RANK #461 of 1000
  • DEATH 46 death-typed
  • INJ 972 injury-typed
  • MALF 1,218 malfunction
  • SPAN 1994–2026
  • PEAK 2023: 619
  • PHOTO Circuit, Breathing

Nearest event-volume peer: Circuit, Breathing (W Connector, Adaptor, Y Piece) (8 report gap)

Catheter, Peritoneal, Long-Term Indwelling sits #461 of 1000 among tracked device types with 2,355 MAUDE reports spanning 1994–2026. 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 sit below the device-type norm

Catheter, Peritoneal, Long-Term Indwelling carries 51.7% MALFUNCTION-coded reports, 13.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.0% corpus 1.5% · near corpus mean (+0.4 pp)
  • INJ 41.3% corpus 30.3% · above corpus mean (+11.0 pp)
  • MALF 51.7% corpus 64.8% · below corpus mean (-13.1 pp)

Lead product-problem code Break is 20% of coded problems · Lead manufacturer UNKNOWN accounts for 51% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Catheter, Peritoneal, Long-Term Indwelling in the event-volume neighbourhood

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

reports

What this shows Catheter, Peritoneal, Long-Term Indwelling carries 2,355 MAUDE reports, ranked #461 of 1000.

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

Event Types

Malfunction 1,218 (51.7%)
Injury 972 (41.3%)
Other 98 (4.2%)
Death 46 (2.0%)
21 (0.9%)

Patient Outcomes

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

1,706 (67.6%)
Required Intervention 266 (10.5%)
Other 242 (9.6%)
R 95 (3.8%)
Hospitalization 95 (3.8%)
O 41 (1.6%)
Death 27 (1.1%)
H 21 (0.8%)
Life Threatening 13 (0.5%)
D 10 (0.4%)
L 7 (0.3%)
S 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Break 388
Hole In Material 181
Leak/Splash 180
Adverse Event Without Identified Device or Use Problem 169
Migration 108
Fluid/Blood Leak 103
Product Quality Problem 84
Insufficient Device Problem Information 75
Obstruction of Flow 69
Explanted 66
Malposition of Device 65
Migration or Expulsion of Device 65
Appropriate Device Problem Term/Code Not Available 62
Crack 57
Replace 57
Detachment of Device or Device Component 50
Connection Problem 49
Material Puncture/Hole 49
Improper or Incorrect Procedure or Method 46
Infusion or Flow Problem 46

Yearly Trend

94
1994: 1
95
1995: 4
96
1996: 10
97
1997: 17
98
1998: 67
99
1999: 30
00
2000: 32
01
2001: 23
02
2002: 3
03
2003: 6
04
2004: 16
05
2005: 7
06
2006: 14
07
2007: 12
08
2008: 9
09
2009: 75
10
2010: 67
11
2011: 58
12
2012: 37
13
2013: 84
14
2014: 66
15
2015: 61
16
2016: 38
17
2017: 75
18
2018: 137
19
2019: 53
20
2020: 94
21
2021: 78
22
2022: 102
23
2023: 619
24
2024: 149
25
2025: 141
26
2026: 170

Reports fell to 141 in 2025, down from an average of 384 in the two years before.

Related Entities for Catheter, Peritoneal, Long-Term Indwelling

Event Locations

1,384 (58.8%)
I 423 (18.0%)
HOSPITAL 388 (16.5%)
HOME 50 (2.1%)
OUTPATIENT TREATMENT FACILITY 36 (1.5%)
UNKNOWN 22 (0.9%)
OTHER 17 (0.7%)
NO INFORMATION 13 (0.6%)
INVALID DATA 12 (0.5%)
NOT APPLICABLE 8 (0.3%)
HOSPICE 2 (0.1%)

Compare UNKNOWN vs COVIDIEN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Peritoneal, Long-Term Indwelling: 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 (2,355 here).

Similar death-typed counts

Nearest other device types by death-typed report count (46 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Peritoneal, Long-Term Indwelling 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 Catheter, Peritoneal, Long-Term Indwelling; 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.