Devices › System, blood culturing
Device brand name · System blood culturing
BD BACTEC Plus Aerobic/F Culture Vials (plastic): medical device reports filed with FDA
1,068 reports name it, 2021–2026. Manufacturer given most often on reports: Becton Dickinson Caribe. Product code MDB.
- 1,068
- device reports naming the brand
- 0% of all MAUDE reports · about 194 a year
- 82
- reports, 12 months to August 2026
- 147 in the 12 months before
- 95.8%
- classified as malfunction
- 97.3% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,068 medical device reports received by FDA name the brand "BD BACTEC Plus Aerobic/F Culture Vials (plastic)" (system blood culturing); the manufacturer given most often on reports is Becton Dickinson Caribe; received from January 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
82 reports arrived in the 12 months to August 2026, down 44% from 147 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 (95.8%), injury (4.1%) and death (0.1%); across all system, blood culturing reports (product code MDB) death is recorded in 0.2% and malfunction in 97.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are false positive result (59.2%), incorrect, inadequate or imprecise result or readings (25.3%) and contamination (11.7%). The patient problems coded most often are bacterial infection, misdiagnosis and blister. 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 6,422 reports carrying product code MDB. 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 |
|---|---|---|---|
| False positive result | 632 | 59.2% | 38.2% |
| Incorrect, inadequate or imprecise result or readings | 270 | 25.3% | 41.5% |
| Contamination | 125 | 11.7% | 7.1% |
| Leak/splashthe device leaked | 27 | 2.5% | 1.9% |
| Device markings/labelling problema problem with the device markings or label | 21 | 2% | 2.2% |
| False negative result | 19 | 1.8% | 7.3% |
| Contamination of device ingredient or reagent | 14 | 1.3% | 0.7% |
| Inaccurate information | 5 | 0.5% | 0.1% |
| Missing information | 3 | 0.3% | 0.3% |
| Product quality problem | 2 | 0.2% | 0% |
| Audible prompt/feedback problem | 1 | 0.1% | 0% |
| Device contamination with chemical or other material | 1 | 0.1% | 0.2% |
| Device ingredient or reagent problem | 1 | 0.1% | 0.1% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.1% | 0% |
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 |
|---|---|---|
| Bacterial infectiona bacterial infection | 5 | 0.5% |
| Misdiagnosis | 4 | 0.4% |
| Blistera blister | 1 | 0.1% |
| Pleural effusionfluid around the lung | 1 | 0.1% |
| Sepsisa severe body-wide response to infection | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | Product code MDB | All MAUDE reports |
|---|---|---|---|
| Reports | 1,068 | 6,422 | 26,136,888 |
| Share of that pool | — | 16.6% | 0% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 4.1% | 2.4% | 36.2% |
| Classified as malfunction | 95.8% | 97.3% | 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 MDB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| BD BACTEC MGIT Mycobacteria Growth Indicator Tubes | 1,224 | 108 | 0% |
| BD BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | 787 | 99 | 0.1% |
| Bd Bactec Fx Instrument Top Packaged | 448 | 0 | 0.2% |
| Bd Bactec Peds Plus / F Culture Vials Plastic | 330 | 79 | 0% |
| Bd Bbl Mgit Mycobacteria Growth Indicator Tubes 7ml | 314 | 10 | 0% |
| BD BACTEC Plus Anaerobic/F Culture Vials (plastic) | 228 | 99 | 0% |
| BD BACTEC MGIT 960 Supplement Kit | 220 | 71 | 0% |
| Mynxgrip Vascular Closure Device 6f-7f | 1,171 | 0 | 0.6% |
| BD BACTEC MGIT 960 SIRE Kit | 173 | 94 | 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 BACTEC Plus Aerobic/F Culture Vials (plastic) reports
How many FDA reports name BD BACTEC Plus Aerobic/F Culture Vials (plastic)?
1,068 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 82 in the latest 12 months.
What kinds of events are reported?
malfunction (95.8%), injury (4.1%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
false positive result (59.2%), incorrect, inadequate or imprecise result or readings (25.3%), contamination (11.7%), leak/splash (2.5%) and device markings/labelling problem (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 BACTEC Plus Aerobic/F Culture Vials (plastic) 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.