2026 data FDA MAUDE openFDA FDA Class II

Set, Administration, For Peritoneal Dialysis, Disposable

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 Set MID-BOOK · MAUDE

#55 of 1000 · 72,142 reports · 1994–2026

  • BOOK 72,142 reports
  • RANK #55 of 1000
  • DEATH 2,402 death-typed
  • INJ 45,870 injury-typed
  • MALF 23,769 malfunction
  • SPAN 1994–2026
  • PEAK 2014: 7,680
  • PHOTO System

Nearest event-volume peer: System, Endovascular Graft, Aortic Aneurysm Treatment (338 report gap)

Set, Administration, For Peritoneal Dialysis, Disposable sits #55 of 1000 among tracked device types with 72,142 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 →

Injury-coded reports run above the device-type norm

Set carries 63.6% INJURY-coded reports, 33.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.3% corpus 1.5% · above corpus mean (+1.8 pp)
  • INJ 63.6% corpus 30.3% · above corpus mean (+33.3 pp)
  • MALF 32.9% corpus 64.8% · below corpus mean (-31.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 41% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 58% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Set in the event-volume neighbourhood

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

reports

What this shows Set, Administration, For Peritoneal Dialysis, Disposable carries 72,142 MAUDE reports, ranked #55 of 1000.

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

Event Types

Injury 45,870 (63.6%)
Malfunction 23,769 (32.9%)
Death 2,402 (3.3%)
64 (0.1%)
Other 37 (0.1%)

Patient Outcomes

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

Hospitalization 24,150 (26.2%)
23,640 (25.6%)
R 17,219 (18.7%)
Required Intervention 14,056 (15.2%)
Other 7,749 (8.4%)
Death 2,377 (2.6%)
H 2,330 (2.5%)
O 490 (0.5%)
D 103 (0.1%)
L 26 (0.0%)
Life Threatening 15 (0.0%)
Congenital Anomaly 10 (0.0%)
S 7 (0.0%)
Disability 3 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 30,563
Improper or Incorrect Procedure or Method 9,489
Insufficient Device Problem Information 6,655
Fluid/Blood Leak 5,389
Contamination 3,462
Detachment of Device or Device Component 3,305
Disconnection 3,196
Leak/Splash 2,155
Crack 2,082
Break 1,480
Connection Problem 1,075
Loose or Intermittent Connection 917
Replace 859
Component(s), broken 823
Product Quality Problem 744
Detachment Of Device Component 585
Material Separation 533
Failure to Disconnect 492
Device Displays Incorrect Message 476
Difficult to Open or Close 449

Yearly Trend

94
1994: 7
95
1995: 4
96
1996: 18
97
1997: 76
98
1998: 712
99
1999: 321
00
2000: 273
01
2001: 266
02
2002: 410
03
2003: 307
04
2004: 309
05
2005: 1,118
06
2006: 718
07
2007: 219
08
2008: 411
09
2009: 233
10
2010: 1,879
11
2011: 4,315
12
2012: 4,294
13
2013: 5,622
14
2014: 7,680
15
2015: 6,870
16
2016: 7,045
17
2017: 4,636
18
2018: 3,379
19
2019: 2,456
20
2020: 2,870
21
2021: 3,167
22
2022: 2,927
23
2023: 2,947
24
2024: 3,113
25
2025: 2,491
26
2026: 1,049

Reports in 2025 (2,491) held close to the prior two-year average of 3,030.

Related Entities for Set, Administration, For Peritoneal Dialysis, Disposable

Event Locations

45,793 (63.5%)
I 26,086 (36.2%)
HOME 148 (0.2%)
HOSPITAL 60 (0.1%)
OTHER 20 (0.0%)
NO INFORMATION 15 (0.0%)
INVALID DATA 6 (0.0%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)
DIALYSIS CENTER 3 (0.0%)
NOT APPLICABLE 3 (0.0%)
UNKNOWN 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare BAXTER HEALTHCARE CORPORATION vs BAXTER HEALTHCARE - MOUNTAIN HOME →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Set: 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 (72,142 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2,402 here), distinct from the volume row.

Disclaimer: MAUDE figures for Set 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 Set; 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.