2026 data FDA MAUDE openFDA FDA Class II

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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 §878.4850 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Single Use Only Blood Lancet With An Integr… MID-BOOK · MAUDE

#180 of 1000 · 14,104 reports · 1993–2026

  • BOOK 14,104 reports
  • RANK #180 of 1000
  • DEATH 2 death-typed
  • INJ 831 injury-typed
  • MALF 13,186 malfunction
  • SPAN 1993–2026
  • PEAK 2012: 1,573
  • PHOTO Endoscope

Nearest event-volume peer: Endoscope, Accessories, Narrow Band Spectrum (185 report gap)

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature sits #180 of 1000 among tracked device types with 14,104 MAUDE reports spanning 1993–2026. 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

Single Use Only Blood Lancet With An Integr… carries 93.5% MALFUNCTION-coded reports, 28.7pp 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 5.9% corpus 30.3% · below corpus mean (-24.4 pp)
  • MALF 93.5% corpus 64.8% · above corpus mean (+28.7 pp)

Lead product-problem code Retraction Problem is 82% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 73% of manufacturer-tagged reports · Top event location U is 26% of location-tagged rows .

Single Use Only Blood Lancet With An Integr… in the event-volume neighbourhood

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

reports

What this shows Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature carries 14,104 MAUDE reports, ranked #180 of 1000.

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

Event Types

Malfunction 13,186 (93.5%)
Injury 831 (5.9%)
Other 66 (0.5%)
19 (0.1%)
Death 2 (0.0%)

Patient Outcomes

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

13,068 (91.6%)
Other 427 (3.0%)
Required Intervention 329 (2.3%)
Life Threatening 199 (1.4%)
R 130 (0.9%)
Hospitalization 73 (0.5%)
L 26 (0.2%)
O 7 (0.0%)
S 5 (0.0%)
Disability 4 (0.0%)
H 2 (0.0%)
Death 2 (0.0%)

Top Product Problems

Retraction Problem 12,129
Replace 804
Needle, unsheathed 220
Spring loading mechanism problem 199
Insufficient Device Problem Information 180
Delivered as Unsterile Product 152
Break 146
Material Protrusion/Extrusion 139
Incorrect, Inadequate or Imprecise Result or Readings 121
Material Fragmentation 104
Other (for use when an appropriate device code cannot be identified) 79
Device Damaged Prior to Use 66
Failure to Fire 61
Adverse Event Without Identified Device or Use Problem 60
Product Quality Problem 54
Sticking 53
Difficult or Delayed Activation 46
Unknown (for use when the device problem is not known) 46
Physical Property Issue 44
Detachment Of Device Component 43

Yearly Trend

93
1993: 1
94
1994: 9
95
1995: 2
96
1996: 7
97
1997: 9
98
1998: 11
99
1999: 16
00
2000: 16
01
2001: 19
02
2002: 21
03
2003: 12
04
2004: 14
05
2005: 48
06
2006: 340
07
2007: 1,206
08
2008: 1,100
09
2009: 882
10
2010: 910
11
2011: 1,493
12
2012: 1,573
13
2013: 1,301
14
2014: 890
15
2015: 781
16
2016: 539
17
2017: 531
18
2018: 534
19
2019: 399
20
2020: 313
21
2021: 245
22
2022: 254
23
2023: 282
24
2024: 243
25
2025: 47
26
2026: 56

Reports fell to 47 in 2025, down from an average of 263 in the two years before.

Related Entities for Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Event Locations

U 3,669 (26.0%)
OTHER 3,414 (24.2%)
2,234 (15.8%)
HOME 1,917 (13.6%)
I 1,722 (12.2%)
UNKNOWN 456 (3.2%)
HOSPITAL 250 (1.8%)
LABORATORY 185 (1.3%)
SCHOOL 70 (0.5%)
NURSING HOME 40 (0.3%)
NO INFORMATION 33 (0.2%)
PATIENT'S HOME 32 (0.2%)
NOT APPLICABLE 30 (0.2%)
CLINIC - WALK IN, OTHER 15 (0.1%)
AMBULATORY HEALTH CARE FACILITY 11 (0.1%)
LONG-TERM CARE FACILITY 5 (0.0%)
OUTPATIENT TREATMENT FACILITY 5 (0.0%)
INVALID DATA 4 (0.0%)
RETIREMENT HOME 4 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
REHABILITATION CENTER 2 (0.0%)
DIALYSIS CENTER 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
PUBLIC BUILDING 1 (0.0%)

Compare ROCHE DIAGNOSTICS vs ROCHE DIABETES CARE, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Single Use Only Blood Lancet With An Integr…: 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 (14,104 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Single Use Only Blood Lancet With An Integr… 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 Single Use Only Blood Lancet With An Integr…; 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.