Introcan Safety ® 2 4242004-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® 2 IV Catheter - 22 Ga. x 1.0 in. · Class 2
All models of Introcan Safety 2 (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04046955745869), received between Sep 8, 2025 and Mar 26, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fail-Safe Problem8
- Contamination /Decontamination Problem4
- Detachment of Device or Device Component3
- Break2
- Difficult to Remove1
- Leak/Splash1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Needle Stick/Puncture2
- Exposure to Body Fluids1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: EMAIL RECEIVED: "WE RECEIVED A REPORT THAT ON (B)(6) 2026, AN RN ON THE FOURTH FLOOR AT TRADITION HOSPITAL COMPLETED IV INSERTION WITH CATALOG 4242004-02, LOT#25M02G8B05. THE SAFETY HAD MALFUNCTIONED AND WAS NOT FULLY ENGAGED/NOT COVERING NEEDLE RESULTING IN A NEEDLE STICK INJURY WHILE CLEANING UP THEIR WORKSPACE. TO MY KNOWLEDGE, THE SAMPLE WAS NOT SAVED." NEEDLESTICK INJURY WITH IS2. PATIENT INJURY NO.
Patient problems: Needle Stick/Puncture
MAUDE report 24697914 ↗MalfunctionFeb 4, 2026Break
ACCORDING TO THE COMPLAINANT, PRIOR TO USE, AN ISSUE WITH THE INTROCAN SAFETY 2 IV CATHETER WAS IDENTIFIED. AN IMAGE WAS SUPPLIED BY THE REPORTER WHICH REVEALED THAT THE NEEDLE AND CATHETER WERE BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257061 ↗MalfunctionDec 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: ISSUE: BROWN LIQUID IN THE CENTER OF THE CATHETER HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23881540 ↗MalfunctionDec 19, 2025Detachment of Device or Device Component; Fail-Safe Problem; Detachment of Device or Device Component; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: INTROCAN SAFETY 2, 22G SAFETY FAILED WHEN NEEDLE WAS RETRACTED THROUGH THE HUB RESULTING IN AN EXPOSED NEEDLE TIP. THE INNER WRKINGS OF THE HUB WERE ALSO REMOVED AND APPEAR TO HAVE BEEN CAUGHT ON THE SAFETY CLIP. IMAGE AND EMAIL FROM THE CUSTOMER ATTACHED. THE DEVICE WAS NOT RETAINED AND THE LOT NUMBER WAS NOT RECORDED. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851203 ↗MalfunctionDec 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
CALL TO CUSTOMER MADE BY THE COMPLAINT ADVOCATE CONFIRMED THAT THE UNANNOUNCED SAMPLES WAS ANOTHER DEVICE NOTED TO HAVE A SMALL AREA OF YELLOW AT THE TIP IN FRONT OF THE VALVE. SPOKE TO REPORTER (B)(6). CALL MADE AT 2:11 ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719993 ↗MalfunctionDec 3, 2025Difficult to Remove; Fail-Safe Problem; Material Deformation; Difficult to Remove; Fail-Safe Problem; Material Deformation
AS REPORTED BY THE USER FACILITY: SAFETY MECHANISM CAUGHT ON CATHETER. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706905 ↗MalfunctionDec 3, 2025Fail-Safe Problem; Fail-Safe Problem
ACCORDING TO THE COMPLAINANT, THE SAFETY MECHANISM WAS CAUGHT ON THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704366 ↗MalfunctionNov 11, 2025Detachment of Device or Device Component; Fail-Safe Problem; Detachment of Device or Device Component; Fail-Safe Problem
ACCORDING TO THE COMPLAINANT THE SAFETY SHIELD APPEARS TO BE STUCK IN THE BLOOD CONTROL SEPTUM, THEY BOTH CAME OUT OF THE HUB, AND THE SAFETY DID NOT ENGAGE LEAVING THE NEEDLE TIP EXPOSED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523617 ↗MalfunctionNov 7, 2025Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WHEN THE CLINICIAN REMOVED THE NEEDLE, THE SAFETY CLIP DID NOT ENGAGE AS THE BLOOD CONTROL VALVE CAME OUT WITH NEEDLE AND BLOCKED THE SAFETY CLIP FROM ENGAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496800 ↗MalfunctionOct 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, PRIOR TO USE, A 22 GAUGE (G) IV CATHETER WAS OBSERVED TO HAVE A YELLOW DISCOLORATION INSIDE THE BLUE HUB NEAR THE TIP IN FRONT OF THE VALVE. UPON INSPECTION OF THE INVENTORY, TWO ADDITIONAL 22G IV CATHETERS FROM THE SAME LOT WERE FOUND TO HAVE SIMILAR YELLOW DISCOLORATION IN THE SAME LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372488 ↗MalfunctionOct 22, 2025Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: 22G INTROCAN SAFETY2 WHEN SYTLET REMOVED, BLOOD CONTROL SEPTUM WAS ATTACHED TO THE STYLET AND SAFETY MECHANISM DID NOT ENGAGE. PATIENT INJURY NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357812 ↗MalfunctionSep 19, 2025Break; Break
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION HOLE IN IVC AND SHEARING THE SHEATH DETAILED INQUIRY DESCRIPTION THERE APPEARS TO BE A HOLE IN THE CATHLONS NEXT TO THE PLASTIC HUB ALSO SEVERAL OF THESE ARE SHEARING THE SHEATH ON INSERTION.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 23100447 ↗MalfunctionSep 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION THE NURSES FOUND SMALL PIECES OF PLASTIC ON THE OUTSIDE OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096126 ↗MalfunctionSep 9, 2025Leak/Splash; Leak/Splash
ACCORDING TO THE COMPLAINANT, A CATHETER LEAKAGE OCCURRED. REPORTEDLY, THE INCIDENT RESULTED IN BLOOD BEING SPLASHED INTO AN EMPLOYEE'S FACE RESULTING IN BLOODBORNE PATHOGEN EXPOSURE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Exposure to Body Fluids
MAUDE report 23004242 ↗MalfunctionSep 8, 2025Detachment of Device or Device Component; Fail-Safe Problem; Detachment of Device or Device Component; Fail-Safe Problem
ACCORDING TO THE EVENT DESCRIPTION DURING THE DEMONSTRATION OF THE PRODUCT THE SEPTUM CAME OUT WITH NEEDLE/SAFETY SHIELD. THE SAFETY SHIELD DIDN'T CLAMP OVER TIP OF NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991954 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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