2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#174 of 1000 · 14,056 reports · 1993–2026

  • BOOK 14,056 reports
  • RANK #174 of 1000
  • DEATH 2 death-typed
  • INJ 821 injury-typed
  • MALF 13,148 malfunction
  • SPAN 1993–2026
  • PEAK 2012: 1,573
  • PHOTO Appliance

Nearest event-volume peer: Appliance, Fixation, Spinal Interlaminal (187 report gap)

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature sits #174 of 1000 among tracked device types with 14,056 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 5.8% corpus 30.4% · below corpus mean (-24.6 pp)
  • MALF 93.5% corpus 64.5% · above corpus mean (+29.0 pp)

Lead product-problem code Retraction Problem is 77% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 72% 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 14,056 MAUDE reports, ranked #174 of 1000.

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

Event Types

Malfunction 13,148 (93.5%)
Injury 821 (5.8%)
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.

13,042 (91.7%)
Other 407 (2.9%)
Required Intervention 329 (2.3%)
Life Threatening 199 (1.4%)
R 129 (0.9%)
Hospitalization 72 (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 2,606
Insufficient Information 142
Break 62
Product Quality Problem 49
Delivered as Unsterile Product 48
Material Fragmentation 47
Physical Property Issue 44
Difficult or Delayed Activation 42
Device Contamination with Chemical or Other Material 39
Mechanical Problem 38
Material Protrusion/Extrusion 37
Defective Device 31
Packaging Problem 28
Defective Component 26
Device Damaged Prior to Use 26
Appropriate Term/Code Not Available 25
Device Markings/Labelling Problem 25
Material Integrity Problem 25
Adverse Event Without Identified Device or Use Problem 24
Mechanics Altered 22

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: 8

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

Event Locations

U 3,669 (26.1%)
OTHER 3,414 (24.3%)
2,197 (15.6%)
HOME 1,917 (13.6%)
I 1,722 (12.3%)
UNKNOWN 456 (3.2%)
HOSPITAL 239 (1.7%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Single Use Only Blood Lancet With An Integr…, 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 (14,056 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.