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2026 data FDA MAUDE openFDA FDA Class II

Needle, Fistula

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 §876.5540 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Needle, Fistula LIGHT-BOOK · MAUDE

#754 of 1000 · 761 reports · 1992–2026

  • BOOK 761 reports
  • RANK #754 of 1000
  • DEATH 49 death-typed
  • INJ 352 injury-typed
  • MALF 254 malfunction
  • SPAN 1992–2026
  • PEAK 2004: 59
  • PHOTO Enzyme Linked Immunoa…

Nearest event-volume peer: Enzyme Linked Immunoabsorbent Assay, Rubella (0 report gap)

Needle, Fistula sits #754 of 1000 among tracked device types with 761 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 → · Similar-volume device →

Malfunction reports sit below the device-type norm

Needle, Fistula carries 33.4% MALFUNCTION-coded reports, 31.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 6.4% corpus 1.5% · above corpus mean (+4.9 pp)
  • INJ 46.3% corpus 30.3% · above corpus mean (+16.0 pp)
  • MALF 33.4% corpus 64.8% · below corpus mean (-31.5 pp)

Lead product-problem code Crack is 15% of coded problems · Top event location OUTPATIENT TREATMENT FACILITY is 34% of location-tagged rows .

Needle, Fistula in the event-volume neighbourhood

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

reports

What this shows Needle, Fistula carries 761 MAUDE reports, ranked #754 of 1000.

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

Event Types

Injury 352 (46.3%)
Malfunction 254 (33.4%)
Other 96 (12.6%)
Death 49 (6.4%)
10 (1.3%)

Patient Outcomes

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

Other 301 (36.9%)
270 (33.1%)
Required Intervention 83 (10.2%)
Hospitalization 59 (7.2%)
Death 41 (5.0%)
R 22 (2.7%)
O 11 (1.3%)
H 10 (1.2%)
L 10 (1.2%)
Life Threatening 4 (0.5%)
Invalid Data 2 (0.2%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Crack 122
Leak/Splash 101
Fluid/Blood Leak 75
Replace 70
Adverse Event Without Identified Device or Use Problem 62
Unknown (for use when the device problem is not known) 55
Dislodged 50
Material Separation 45
Disconnection 34
Device Dislodged or Dislocated 29
Detachment Of Device Component 26
Air Leak 22
Difficult to Remove 20
Increase in Pressure 20
Use of Device Problem 20
Component(s), broken 17
Reaction 17
Material Puncture/Hole 15
Break 14
Device, removal of (non-implant) 11

Yearly Trend

92
1992: 3
93
1993: 28
94
1994: 18
95
1995: 3
96
1996: 15
97
1997: 38
98
1998: 13
99
1999: 18
00
2000: 26
01
2001: 52
02
2002: 52
03
2003: 43
04
2004: 59
05
2005: 46
06
2006: 32
07
2007: 13
08
2008: 10
09
2009: 27
10
2010: 17
11
2011: 2
12
2012: 7
13
2013: 6
14
2014: 4
15
2015: 23
16
2016: 21
17
2017: 14
18
2018: 16
19
2019: 21
20
2020: 3
21
2021: 1
22
2022: 1
23
2023: 58
24
2024: 14
25
2025: 33
26
2026: 24

Reports in 2025 (33) held close to the prior two-year average of 36.

Related Entities for Needle, Fistula

Event Locations

OUTPATIENT TREATMENT FACILITY 262 (34.4%)
259 (34.0%)
OTHER 109 (14.3%)
HOSPITAL 65 (8.5%)
DIALYSIS CENTER 20 (2.6%)
INVALID DATA 16 (2.1%)
I 13 (1.7%)
HOME 6 (0.8%)
UNKNOWN 5 (0.7%)
NO INFORMATION 3 (0.4%)
AMBULATORY SURGICAL FACILITY 2 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Needle, Fistula: 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 (761 here).

Enzyme Linked Immunoabsorbent Assay, Rubella 761 Culture Media 762 Table, Radiographic, Tilting 762 Mesh 756

Similar death-typed counts

Nearest other device types by death-typed report count (49 here), distinct from the volume row.

Hexokinase, Glucose 49 Prosthesis 49 Bone Cement, Antibiotic 48 Catheter 50

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Needle, Fistula 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 Needle, Fistula; 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.