Devices › Single use only blood lancet with an integral sharps injury prevention feature
Device brand name · Manual surgical instrument for general use
Bd Microtainer Contact-Activated Lancet: medical device reports filed with FDA
220 reports name it, 2012–2026. Manufacturer given most often on reports: Becton Dickinson. Product code FMK.
- 220
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 10
- reports, 12 months to August 2026
- 5 in the 12 months before
- 80.5%
- classified as malfunction
- 93.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
220 medical device reports received by FDA name the brand "Bd Microtainer Contact-Activated Lancet" (manual surgical instrument for general use); the manufacturer given most often on reports is Becton Dickinson; received from April 2012 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
10 reports arrived in the 12 months to August 2026, up 100% from 5 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (80.5%) and injury (19.5%); across all single use only blood lancet with an integral sharps injury prevention feature reports (product code FMK) death is recorded in 0% and malfunction in 93.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult or delayed activation (16.4%), product quality problem (12.7%) and device contamination with chemical or other material (10.9%). The patient problems coded most often are needle stick/puncture, no patient involvement and hemorrhage/blood loss/bleeding. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 14,110 reports carrying product code FMK. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Difficult or delayed activation | 36 | 16.4% | 0.3% |
| Product quality problem | 28 | 12.7% | 0.4% |
| Device contamination with chemical or other material | 24 | 10.9% | 0.3% |
| Packaging problem | 19 | 8.6% | 0.2% |
| Defective devicethe device was defective | 18 | 8.2% | 0.2% |
| Delivered as unsterile product | 13 | 5.9% | 1.1% |
| Breakthe device broke | 9 | 4.1% | 1% |
| Device damaged prior to usethe device was damaged before use | 9 | 4.1% | 0.5% |
| Device markings/labelling problema problem with the device markings or label | 8 | 3.6% | 0.2% |
| Material protrusion/extrusion | 7 | 3.2% | 0.9% |
| Retraction problem | 7 | 3.2% | 86% |
| Leak/splashthe device leaked | 5 | 2.3% | 0% |
| Material deformation | 5 | 2.3% | 0% |
| Separation problem | 5 | 2.3% | 0% |
| Physical resistance/sticking | 3 | 1.4% | 0% |
| Crackthe device cracked | 2 | 0.9% | 0.2% |
| Defective component | 2 | 0.9% | 0.2% |
| Material separation | 2 | 0.9% | 0.2% |
| Capturing problem | 1 | 0.5% | 0% |
| Component missing | 1 | 0.5% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Needle stick/puncture | 29 | 13.2% |
| No patient involvement | 10 | 4.5% |
| Hemorrhage/blood loss/bleeding | 3 | 1.4% |
| Painpain, site not specified | 3 | 1.4% |
| Device embedded in tissue or plaque | 2 | 0.9% |
| Exposure to body fluids | 2 | 0.9% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.5% |
| Hypersensitivity/allergic reaction | 1 | 0.5% |
| Impaired healingslow healing | 1 | 0.5% |
| Inflammationinflammation | 1 | 0.5% |
| Laceration(s) | 1 | 0.5% |
| Swellingswelling | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bd Microtainer Contact-Activated Lancet | Product code FMK | All MAUDE reports |
|---|---|---|---|
| Reports | 220 | 14,110 | 26,136,888 |
| Share of that pool | — | 1.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 19.5% | 5.9% | 36.2% |
| Classified as malfunction | 80.5% | 93.5% | 62.3% |
| Filed by the manufacturer | 100% | 98.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FMK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Accu-Chek Multiclix | 6,191 | 0 | 0% |
| Softclix Lancet Device | 3,115 | 80 | 0% |
| Softclix Plus Lancet Device | 1,137 | 0 | 0% |
| Accu-Chek Fastclix | 1,063 | 56 | 0% |
| Softclix Plus Gt Lancet Device | 282 | 0 | 0% |
| Safe-T-Pro | 152 | 0 | 0% |
| Softclix Lancets | 157 | 6 | 0% |
| Ot Delica Lancing Device | 196 | 0 | 0% |
| EasyTouch | 407 | 42 | 0% |
| Accu-Chek Mobile Test Strips | 3,527 | 0 | 0% |
| Freestyle | 9,490 | 26 | 0.1% |
| One Touch Lancing Device | 169 | 0 | 0% |
| Accu-Chek | 270 | 0 | 0% |
| Accu-Chek Advantage | 1,290 | 0 | 0.5% |
| Freestyle Flash | 19,422 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Bd Microtainer Contact-Activated Lancet reports
How many FDA reports name Bd Microtainer Contact-Activated Lancet?
220 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 10 in the latest 12 months.
What kinds of events are reported?
malfunction (80.5%) and injury (19.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult or delayed activation (16.4%), product quality problem (12.7%), device contamination with chemical or other material (10.9%), packaging problem (8.6%) and defective device (8.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bd Microtainer Contact-Activated Lancet was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.