Devices › Tubes, vacuum sample, with anticoagulant
Device brand name · Capillary blood collection tube ivd
BD MiniDraw H&H Capillary Blood Collection Tube: medical device reports filed with FDA
156 reports name it, 2024–2026. Manufacturer given most often on reports: Bd Caribe. Product code GIM.
- 156
- device reports naming the brand
- 0% of all MAUDE reports · about 78 a year
- 76
- reports, 12 months to August 2026
- 54 in the 12 months before
- 100%
- classified as malfunction
- 99.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
156 medical device reports received by FDA name the brand "BD MiniDraw H&H Capillary Blood Collection Tube" (capillary blood collection tube ivd); the manufacturer given most often on reports is Bd Caribe; received from July 2024 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
76 reports arrived in the 12 months to August 2026, up 41% from 54 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 (100%); across all tubes, vacuum sample, with anticoagulant reports (product code GIM) death is recorded in 0% and malfunction in 99.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are coagulation in device or device ingredient (48.1%), improper chemical reaction (37.8%) and clumping in device or device ingredient (34.6%). 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 2,002 reports carrying product code GIM. 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 |
|---|---|---|---|
| Coagulation in device or device ingredient | 75 | 48.1% | 9.1% |
| Improper chemical reaction | 59 | 37.8% | 4.3% |
| Clumping in device or device ingredient | 54 | 34.6% | 2.7% |
| Leak/splashthe device leaked | 3 | 1.9% | 10.1% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.6% | 3.8% |
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.
In context
| Measure | BD MiniDraw H&H Capillary Blood Collection Tube | Product code GIM | All MAUDE reports |
|---|---|---|---|
| Reports | 156 | 2,002 | 26,136,888 |
| Share of that pool | — | 7.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 0.3% | 36.2% |
| Classified as malfunction | 100% | 99.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 GIM
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 MiniDraw H&H Capillary Blood Collection Tube reports
How many FDA reports name BD MiniDraw H&H Capillary Blood Collection Tube?
156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 76 in the latest 12 months.
What kinds of events are reported?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
coagulation in device or device ingredient (48.1%), improper chemical reaction (37.8%), clumping in device or device ingredient (34.6%), leak/splash (1.9%) and incorrect, inadequate or imprecise result or readings (0.6%). 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 MiniDraw H&H Capillary Blood Collection Tube 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.