Devices › Catheter, intravascular, therapeutic, short-term less than 30 days
Device brand name · I v safety catheter
Introcan Safety: medical device reports filed with FDA
1,255 reports name it, 2001–2026. Manufacturer given most often on reports: B Braun Melsungen. Product code FOZ.
- 1,255
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 45
- reports, 12 months to August 2026
- 58 in the 12 months before
- 68%
- classified as malfunction
- 83.5% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,255 medical device reports received by FDA name the brand "Introcan Safety" (i v safety catheter); the manufacturer given most often on reports is B Braun Melsungen; received from March 2001 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
45 reports arrived in the 12 months to August 2026, down 22% from 58 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 (68%), other (16.8%) and injury (13.4%); across all catheter, intravascular, therapeutic, short-term less than 30 days reports (product code FOZ) death is recorded in 0.3% and malfunction in 83.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation, positioning or separation problem (24.5%), break (16.8%) and positioning failure (12.6%). The patient problems coded most often are needle stick/puncture, foreign body in patient and device embedded in tissue or plaque. 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 49,301 reports carrying product code FOZ. 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 |
|---|---|---|---|
| Activation, positioning or separation problem | 308 | 24.5% | 0.7% |
| Breakthe device broke | 211 | 16.8% | 10.9% |
| Positioning failure | 158 | 12.6% | 0.3% |
| Fail-safe problem | 85 | 6.8% | 0.5% |
| Protective measures problem | 57 | 4.5% | 0.3% |
| Leak/splashthe device leaked | 53 | 4.2% | 21.4% |
| Fluid/blood leak | 43 | 3.4% | 6.7% |
| Contamination /decontamination problem | 32 | 2.5% | 0.7% |
| Fail-safe design failure | 32 | 2.5% | 0.2% |
| Needle, unsheathed | 27 | 2.2% | 0.1% |
| Device, removal of (non-implant) | 22 | 1.8% | 0.7% |
| Retraction problem | 21 | 1.7% | 9% |
| Detachment of device component | 18 | 1.4% | 1.6% |
| Material puncture/hole | 18 | 1.4% | 2.3% |
| Positioning problem | 18 | 1.4% | 0.1% |
| Component missing | 17 | 1.4% | 0.7% |
| Material separation | 17 | 1.4% | 4.2% |
| Improper or incorrect procedure or method | 16 | 1.3% | 0.5% |
| Detachment of device or device componentpart of the device came off | 14 | 1.1% | 1.3% |
| Difficult to removethe device was hard to remove | 14 | 1.1% | 1.8% |
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.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Needle stick/puncture | 448 | 35.7% |
| Foreign body in patientpart of a device left in the patient | 83 | 6.6% |
| Device embedded in tissue or plaque | 60 | 4.8% |
| Therapy/non-surgical treatment, additional | 57 | 4.5% |
| No patient involvement | 44 | 3.5% |
| Exposure to body fluids | 41 | 3.3% |
| Foreign body, removal of | 27 | 2.2% |
| Vasculitisinflammation of blood vessels | 21 | 1.7% |
| Dural tear | 19 | 1.5% |
| Painpain, site not specified | 17 | 1.4% |
| Surgical procedure | 15 | 1.2% |
| Infiltration into tissue | 13 | 1% |
| Nonresorbable materials, unretrieved in body | 11 | 0.9% |
| Discomfortdiscomfort | 9 | 0.7% |
| Hemorrhage/blood loss/bleeding | 6 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Introcan Safety | Product code FOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,255 | 49,301 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 1 | 3 | 9 |
| Classified as injury | 13.4% | 13.1% | 36.2% |
| Classified as malfunction | 68% | 83.5% | 62.3% |
| Filed by the manufacturer | 81.5% | 89.6% | 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 FOZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Insyte AUTOGUARD | 1,314 | 1,050 | 0% |
| BD Insyte Autoguard | 1,246 | 55 | 0% |
| Bd Insyte Autog Bc | 695 | 0 | 0% |
| Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm | 1,110 | 123 | 0.1% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Nexiva | 385 | 304 | 0% |
| Mahurkar | 1,046 | 6 | 1.1% |
| BD Nexiva | 372 | 14 | 0% |
| Jelco | 363 | 34 | 0% |
| Arrow Pi Cvc Kit 3-L 7 Fr X 20 Cm Agb | 286 | 63 | 1% |
| Arrow Cvc Set 16 Ga X 8 20 Cm | 551 | 0 | 0% |
| Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm | 338 | 12 | 0% |
| Bd Nexiva Single Port | 224 | 0 | 0% |
| Unspecified Bd Catheter | 251 | 0 | 0% |
| Accu-Chek Tender Infusion Set | 839 | 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 Introcan Safety reports
How many FDA reports name Introcan Safety?
1,255 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 45 in the latest 12 months.
What kinds of events are reported?
malfunction (68%), other (16.8%) and injury (13.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation, positioning or separation problem (24.5%), break (16.8%), positioning failure (12.6%), fail-safe problem (6.8%) and protective measures problem (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (81.5%), distributor reports (8.3%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Introcan Safety 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.