2026 data FDA MAUDE openFDA FDA Class I

Arterial Blood Sampling Kit

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §868.1100 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Arterial Blood Sampling Kit LIGHT-BOOK · MAUDE

#942 of 1000 · 433 reports · 1992–2026

  • BOOK 433 reports
  • RANK #942 of 1000
  • DEATH 0 death-typed
  • INJ 58 injury-typed
  • MALF 356 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 30
  • PHOTO Platelet And Plasma S…

Nearest event-volume peer: Platelet And Plasma Separator For Bone Graft Handling (1 report gap)

Arterial Blood Sampling Kit sits #942 of 1000 among tracked device types with 433 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 →

Malfunction reports run above the device-type norm

Arterial Blood Sampling Kit carries 82.2% MALFUNCTION-coded reports, 17.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 13.4% corpus 30.3% · below corpus mean (-16.9 pp)
  • MALF 82.2% corpus 64.8% · above corpus mean (+17.4 pp)

Lead product-problem code Detachment Of Device Component is 11% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 78% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Arterial Blood Sampling Kit in the event-volume neighbourhood

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

reports

What this shows Arterial Blood Sampling Kit carries 433 MAUDE reports, ranked #942 of 1000.

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

Event Types

Malfunction 356 (82.2%)
Injury 58 (13.4%)
Other 16 (3.7%)
3 (0.7%)

Patient Outcomes

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

307 (70.4%)
Other 88 (20.2%)
Required Intervention 31 (7.1%)
Hospitalization 5 (1.1%)
R 3 (0.7%)
Life Threatening 2 (0.5%)

Top Product Problems

Detachment Of Device Component 38
Fluid/Blood Leak 36
Leak/Splash 35
Detachment of Device or Device Component 30
Disconnection 30
Break 20
Material Separation 20
Crack 17
Tube(s), buckling of 16
Incorrect, Inadequate or Imprecise Result or Readings 14
Component Missing 12
Air Leak 10
Sticking 10
Mechanical Problem 9
Unknown (for use when the device problem is not known) 9
Improper or Incorrect Procedure or Method 7
Needle, unsheathed 7
Air/Gas in Device 6
Bent 6
Contamination 6

Yearly Trend

92
1992: 1
94
1994: 7
96
1996: 11
97
1997: 18
98
1998: 11
99
1999: 6
00
2000: 11
01
2001: 16
02
2002: 11
03
2003: 16
04
2004: 16
05
2005: 13
06
2006: 13
07
2007: 5
08
2008: 10
09
2009: 7
10
2010: 20
11
2011: 6
12
2012: 14
13
2013: 13
14
2014: 6
15
2015: 10
16
2016: 30
17
2017: 22
18
2018: 15
19
2019: 19
20
2020: 10
21
2021: 24
22
2022: 13
23
2023: 13
24
2024: 25
25
2025: 20
26
2026: 1

Reports in 2025 (20) held close to the prior two-year average of 19.

Related Entities for Arterial Blood Sampling Kit

Event Locations

191 (44.1%)
HOSPITAL 113 (26.1%)
I 111 (25.6%)
INVALID DATA 11 (2.5%)
NO INFORMATION 7 (1.6%)

Compare SMITHS MEDICAL ASD, INC. vs CAREFUSION, INC →

Nationwide devices with a comparable report-volume footprint

Arterial Blood Sampling Kit carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Disclaimer: MAUDE figures for Arterial Blood Sampling Kit 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 Arterial Blood Sampling Kit; 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.