INTROCAN SAFETY® 3 4251131-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® 3 Closed IV Catheter 18 Ga. x 1.25 in., PUR, Winged · Class 2
All models of INTROCAN SAFETY 3 (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04046964014079), received between Aug 9, 2017 and Mar 31, 2025 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Leak/Splash4
- Fluid/Blood Leak3
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient2
- No Consequences Or Impact To Patient2
- Blood Loss1
- Chest Pain1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION BLOOD CONTROL NOT WORKING DETAILED INQUIRY DESCRIPTION BLEEDING OUT THE SAFETY END DESCRIPTION OF THE PATIENT EVENT BLOOD BLEEDING OUT END OF IV AFTER STARTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21731011 ↗MalfunctionDec 5, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLOOD CONTROL VALVE FAILED. DETAILED INQUIRY DESCRIPTION: CLINICIAN REPORTED THAT AFTER IV START, HE REMOVED THE STYLET AND THE BLOOD SEPTUM DID NOT CLOSE, ALLOWING BLOOD TO FREEFLOW FROM THE CATHETER HUB. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18271200 ↗InjuryJun 7, 2023Break; Break
AS REPORTED BY THE USER FACILITY: THE CATHETER BROKE OFF INTO THE PATIENT'S ARM. WHEN THE CATHETER WAS INSERTED EVERYTHING WAS FINE BUT WHEN THEY WENT TO REMOVE THE CATHETER THERE WAS LIKE TENSION WHEN PULLING IT OUT. PART OF THE CATHETER WAS MISSING. PATIENT WAS FINE WHEN SHE LEFT THE SPA. PATIENT HAD GONE TO THE ER TO HAVE AN ULTRASOUND DONE. ULTRASOUND DIDN'T FIND ANYTHING, SO THE HOSPITAL RELEASED HER. PATIENT IS SCHEDULED TO HAVE A CT SCAN. PATIENT WENT BACK TO THE EMERGENCY ROOM FOR CHEST PAIN. PATIENT IS A FEMALE BORN IN 1983 (40 YRS OLD).
Patient problems: Chest Pain; Foreign Body In Patient
MAUDE report 17081158 ↗MalfunctionOct 11, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACITITY: END USER STATED BLOOD WAS LEAKING FROM HUB AFTER PULLING STYLET OUT. IT HAPPENED WITH THE 18G AND 20G.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12604883 ↗MalfunctionSep 9, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: PRE-OP NURSES STATING INTROCAN SAFETY 3 IV CATHETER IS LEAKING FROM HUB. RECEIVED EMAIL FROM PRE-OP EDUCATOR STATING SEVERAL NURSES WERE HAVING ISSUES WITH LEAKING FROM THE HUB OF IS3. MET WITH EDUCATOR AND PRE-OP DIRECTOR ON 8/18 TO DISCUSS. WE DETERMINED THAT LEAKING WAS NOT BLOOD COMING OUT OF HUB DUE TO LEAVING STYLET IN TOO LONG. THE LEAKING CAME AFTER MAKING THE CONNECTION WITH THE RYMED EXTENSION SET 460203 TO THE IS3 CATHETER WHERE FLUID WAS COMING OUT FROM THE CONNECTION SITE. I HAVE A SAMPLE OF THE CATHETER WITH SAME LOT# ALONG WITH A SAMPLE OF THE RYMED EXTESION SET THAT I CAN SEND TO ANALYZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12448120 ↗MalfunctionDec 20, 2019Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: WHILE CLEANING UP, CLEANING UP THE NURSE NOTICED THE SAFETY CLIP WAS LOOSE AND DOWN BY THE FLASHPLUG AREA OF THE NEEDLE, NOT COVERING THE NEEDLE. NO HARM DONE OR REPORTED AS SHE DISPOSED OF THE NEEDLE WITHOUT INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9503943 ↗MalfunctionSep 27, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: CATHETER OBSERVED LEAKING BLOOD FROM THE JUNCTION OF THE CANNULA AND THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9131836 ↗MalfunctionApr 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: VALVE DID WORK PROPERLY, AND BLOOD LEAKED OUT OF THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8503499 ↗MalfunctionDec 12, 2018Break; Break
AS REPORTED BY USER FACILITY: WHEN THE CATHETER WAS REMOVED FROM THE PATIENT'S RIGHT FOREARM, IT APPEARED TO BE MISSING THE LAST 1MM. STAFF BELIEVE THE LAST 1MM OF CATHETER BROKE OFF INTO THE PATIENT'S FOREARM. PATIENT WAS X-RAYED, AND NOTHING WAS SEEN.
Patient problems: Foreign Body In Patient
MAUDE report 8154854 ↗MalfunctionJul 27, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: WHEN THE NEEDLE WAS PULLED OUT BLOOD CAME OUT THE CATHETER HUB. NO PATIENT INJURY.
Patient problems: Blood Loss; No Known Impact Or Consequence To Patient
MAUDE report 7726025 ↗MalfunctionAug 9, 2017Break; Break
AS REPORTED BY USER FACILITY: EVENT 2. THE BACK FELL OFF OF THE FLASHBACK CHAMBER, WHICH CAUSED A DROP OF BLOOD TO LEAK. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6777853 ↗MalfunctionAug 9, 2017Break; Break
AS REPORTED BY USER FACILITY: EVENT 1. THE BACK FELL OFF OF THE FLASHBACK CHAMBER, WHICH CAUSED A DROP OF BLOOD TO LEAK. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6777829 ↗
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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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