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2025 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Needle, Fistula LIGHT-BOOK · MAUDE

#748 of 1000 · 737 reports · 1992–2025

  • BOOK 737 reports
  • RANK #748 of 1000
  • DEATH 49 death-typed
  • INJ 332 injury-typed
  • MALF 250 malfunction
  • SPAN 1992–2025
  • PEAK 2004: 59
  • PHOTO Culture Media

Nearest event-volume peer: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (4 report gap)

Needle, Fistula sits #748 of 1000 among tracked device types with 737 MAUDE reports spanning 1992–2025. 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 →

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 6.6% corpus 1.5% · above corpus mean (+5.1 pp)
  • INJ 45.0% corpus 30.4% · above corpus mean (+14.6 pp)
  • MALF 33.9% corpus 64.5% · below corpus mean (-30.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Top event location OUTPATIENT TREATMENT FACILITY is 36% 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 737 MAUDE reports, ranked #748 of 1000.

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

Event Types

Injury 332 (45.0%)
Malfunction 250 (33.9%)
Other 96 (13.0%)
Death 49 (6.6%)
10 (1.4%)

Patient Outcomes

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

Other 290 (36.8%)
260 (33.0%)
Required Intervention 81 (10.3%)
Hospitalization 58 (7.4%)
Death 41 (5.2%)
R 21 (2.7%)
H 10 (1.3%)
L 10 (1.3%)
O 9 (1.1%)
Life Threatening 4 (0.5%)
Invalid Data 2 (0.3%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 60
Device Dislodged or Dislocated 26
Fluid/Blood Leak 23
Detachment of Device or Device Component 10
Disconnection 6
Obstruction of Flow 6
Output Problem 6
Expulsion 5
Leak/Splash 5
Device Slipped 4
Component Missing 3
Device Difficult to Setup or Prepare 3
Migration or Expulsion of Device 3
Unintended Movement 3
Use of Device Problem 3
Break 2
Detachment Of Device Component 2
Device Operational Issue 2
Difficult to Remove 2
Fail-Safe Did Not Operate 2

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

Related Entities for Needle, Fistula

Event Locations

OUTPATIENT TREATMENT FACILITY 262 (35.5%)
235 (31.9%)
OTHER 109 (14.8%)
HOSPITAL 65 (8.8%)
DIALYSIS CENTER 20 (2.7%)
INVALID DATA 16 (2.2%)
I 13 (1.8%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Needle, Fistula, 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 (737 here).

Culture Media 733 Pacemaker Lead Adaptor 733 Catheter, Balloon Type 743 Extractor, Vacuum, Fetal 730

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 Pulmonic Valved Conduit 48 Unit, Cryosurgical, Accessories 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.