INTROCAN SAFETY® 3 4251129-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® 3 Closed IV Catheter 20 Ga. x 1 in., PUR, Winged · Class 2
All models of INTROCAN SAFETY 3 (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Introcan Safety 3 winged IV catheter is a short-term closed IV catheter used for inserting into veins. The 43 reports mostly describe leaking or splashing at the insertion site and blood flowing backward through the catheter because the valve does not seal, plus needle safety covers that fail to slide over the needle or trap the needle so it cannot be removed. Reports also mention blood loss and a needle stick. There are 2 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04046964014031), received between Jun 13, 2017 and Feb 11, 2026 — classified as 1 injury, 42 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (15 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
- Leak/Splash15
- Fail-Safe Problem10
- Fluid/Blood Leak9
- Protective Measures Problem3
- Break2
- Mechanical Problem2
- Contamination /Decontamination Problem1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Needle Stick/Puncture8
- No Consequences Or Impact To Patient5
- Blood Loss4
- No Known Impact Or Consequence To Patient3
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Fail-Safe Problem
AS REPORTED BY USER FACILITY: IV CATHETER WAS USED FOR IV INSERTION. THERE WAS NO ISSUE WITH THE INSERTION. WHEN THE NURSE RETRACTED THE NEEDLE FROM THE CATHETER, THE PROTECTIVE COVER DID NOT COVER THE NEEDLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312667 ↗MalfunctionDec 23, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: THE VALVES ARE FAULTY, ALLOWING BLOOD TO GO BACKWARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877714 ↗MalfunctionOct 22, 2025Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: OR COORDINATOR STATES THAT A COUPLE WEEKS AGO A 20G IS3 CATHETER WAS PLACED AND WHEN RETRACTING THE NEEDLE THE SAFETY MECHANISM ENGAGED BUT DID NOT FULLY COVER THE TIP OF THE NEEDLE LEAVING AN EXPOSED SHARP. THE NEEDLE WAS NOT RETAINED. THE LOT NUMBER WAS NOT CONFIRMED. THE LOT RECORDED HERE IS WHAT IS CURRENTLY ON THE SHELF AT THE FACILITY. PATIENT INJURY NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357896 ↗MalfunctionSep 18, 2025Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION NEEDLE GOT CAUGHT IN SAFETY AND COULD NOT REMOVE FROM CATHETER HUB DETAILED INQUIRY DESCRIPTION WHILE REMOVING STYLET, NEEDLE WAS CAUGHT ON SAFETY AND COULD NOT BE REMOVED OR ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23088954 ↗MalfunctionJul 10, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: REASON: VENDOR DEFECTIVE - THEY ARE NOT SELF OCCLUDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467763 ↗MalfunctionJul 1, 2025Leak/Splash; Leak/Splash
ACCORDING TO THE COMPLAINANT, THE DEVICE WAS NOT SELF-OCCLUDING. ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED THAT THE "THE BLOOD CONTROL PART OF THE IV WAS NOT WORKING PROPERLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375853 ↗MalfunctionApr 2, 2025Mechanical Problem; Mechanical Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION FAILED BLOOD CONTROL WHEN INTROCAN SAFETY 3 CLOSED IV CATHETER (MULTI ACCESS BLOOD CONTROL) 20G CATHETER. MULTIPLE STAFF NOTED RECENT INTERMITTENT ISSUES WITH BLOOD CONTROL DEVICE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751002 ↗MalfunctionMar 14, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: INTROCAN SAFETY 3 "BLEEDING BACK." DETAILED INQUIRY DESCRIPTION: THE FOLLOWING IS DIRECTLY FROM THE CUSTOMERS EMAIL NOTIFICATION OF THIS ISSUE: NOVANT HEALTH FORSYTH MEDICAL CENTER HAS BEEN EXPERIENCING MULTIPLE FAILURE EVENTS INVOLVING B BRAUN 20G IV SAFETY 3 CATHETERS, PRODUCT # 4251129-02, LOT # 24K17G8374. TEAM MEMBERS HAVE REPORTED THE FOLLOWING: · "RNS HAVE EXPRESSED THAT THEY BLEED BACK, SIMILAR TO THE ISSUES THE (RECALLED) 22G RECALL NOTED." "THANK YOU FOR REACHING OUT. WE HAVE HAD SEVERAL 20G IV CATHETERS THAT WHEN ADVANCED INTO THE PATIENT'S VEIN, BLOOD WOULD COME OUT OF THE IV CATHETER. USUALLY, THERE IS A SMALL AMOUNT THAT STAYS IN THE CATHETER ITSELF, BUT THESE IN PARTICULAR WOULD LEAK BLOOD. THIS IS SIMILAR TO HOW ANGIOCATHS USED TO FUNCTION PRIOR TO THE ADDITION OF THE VALVES. HOPE THIS IS HELPFUL. THANKS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605881 ↗MalfunctionOct 16, 2024Fail-Safe Problem; Fail-Safe Problem
AS REPROTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION "INTROCAN 3 SAFETY MECHANISM FAILED TO COVER THE END OF THE NEEDLE." DETAILED INQUIRY DESCRIPTION SHARING FOR AWARENESS THAT THE EMERGENCY DEPT. HERE AT SMH HAD ANOTHER IV CATHETER THAT THE SAFETY MECHANISM FAILED TO ENGAGE. SEE RISKMASTER BELOW. "FAILURE BBRAUN 20 GUAGE IV CATHETER SAFETY FEATURE AGAIN DID NOT ENGAGE AT END OF NEEDLE. THE SAFETY FEATURE ENGAGED ABOUT HALF WAY DOWN THE NEEDLE AND LEFT THE TIP OF THE NEEDLE EXPOSED AFTER REMOVED. THIS HAPPENED WITH THIS PT AS WELL AS 1 OTHER PATIENT EARLIER TODAY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20466433 ↗MalfunctionMar 14, 2024Break; Break
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BOKEN INTROCAN SAFETY 3 STYLET. DETAILED INQUIRY DESCRIPTION: THE FOLLOWING STATEMENT IS FROM THE CUSTOMER'S EMAIL: JUST WANTED TO MAKE YOU AWARE THAT ONE OF MY STAFF MEMBERS TRIED TO PLACE IN AN IV WITH THIS PRODUCT AND WHEN OBTAINING BLOOD VISUALIZATION MEANING SHE WAS IN THE VEIN, SHE RETRACTED THE METAL NEEDLE LEAVING THE CATHETER IN PLACE, WHEN SHE TRIED TO FLUSH THE IV TO VERIFY PATENCY SHE COULD NOT FLUSH IT AND WHEN SHE REMOVED IT. THERE WAS A PIECE OF THE METAL NEEDLE STUCK IN THE CATHETER THAT BROKE OFF WHEN THE NEEDLE WAS REMOVED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18903095 ↗MalfunctionJan 29, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLOOD LEAKING AT THE INSERTION SITE AND CATH KINKED. DETAILED INQUIRY DESCRIPTION: BLOOD WAS LEAKING AT THE INSERTION SITE AROUND THE CATHETER AND THE HUB. WHEN THE CATHETER WAS REMOVED, THE CATH WAS KINKED. PLACEMENT WAS IN THE FOREARM. PATIENT INJURY OR DEATH NO. WAS MEDICAL INTERVENTION NECESSARY NO. WAS THERAPY INCOMPLETE, INCORRECT OR INTERRUPTED YES. DESCRIBE: HAD TO PLACE A NEW IV CATH.
Patient problems: Needle Stick/Puncture
MAUDE report 18596338 ↗MalfunctionJan 12, 2024Leak/Splash; Leak/Splash
AS PER MEDWATCH REPORT #MW5149196: SUCCESSFULLY PLACED 20G INTROCAN SAFETY 3 CLOSED IV CATHETER. WHEN FLUSHING IV WITH SALINE, IV CAME APART INTO TWO PIECES. BLOOD AND SALINE WAS FLOWING OUT ONTO BED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18504086 ↗MalfunctionNov 27, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: IS3 FAILED SEPTUM. DETAILED INQUIRY DESCRIPTION: UPON ROUTINE IS3 ROUNDING IN ED, RN STATED THE SEPTUM FAILED WITH IV INSERTION AND CREATED A BLOOD EXPOSURE. IV REMAINED IN PATIENT, FUNCTIONAL, SO DEVICE WAS NOT SAVED FOR REVIEW. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18208401 ↗MalfunctionJul 26, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: DEFECTIVE INTROCAN - PASSIVE SAFETY DID NOT ENGAGE. DESCRIPTION OF DEFECT: SAFETY CLOSURE MECHANISM DID NOT WORK CAUSING NEEDLE STICK TO RN. MIDAS WAS NOT IMMEDIATELY COMPLETED BUT WILL BE COMPLETED MOMENTARILY. RN AND SOURCE PATIENT TESTED AS PER EMPLOYEE EXPOSURE PROTOCOL. STAFF STATED THAT CHECKED ADDITIONAL IV CATHETERS FROM THIS SAME LOT AND THEY WORKED APPROPRIATELY.
Patient problems: Needle Stick/Puncture
MAUDE report 17395949 ↗InjuryJun 15, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: AN INTROCAN 20G X 1IN. WITH A DEFECTIVE SAFETY AND NURSE WAS PUNCTURED WITH THE NEEDLE. THE NURSE IS OKAY BUT RECEIVED PREVENTATIVE ANTIBIOTICS AND ANTIVIRALS- (PATIENT HAS SYPHILIS, HIV/AIDS POSITIVE AND HEP C NEVER TREATED). 20 G PIV STARTED ON PATIENT'S LEFT FOREARM; NEEDLE LOCK ENGAGED. UPON PICKING UP NEEDLE WITH RIGHT HAND, PUNCTURE OCCURRED ON LEFT TOP OF THUMB, SAFETY LOCK NOTED TO SLID DOWN THE NEEDLE, BEING DEFECTIVE. BLOOD NOTED AT PUNCTURE SITE ON LEFT THUMB."
Patient problems: Needle Stick/Puncture
MAUDE report 17134432 ↗MalfunctionMay 9, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION; UPON USE AND REMOVAL OF THE 20G STYLET THE SAFETY MECHANISM FAILED TO ENGAGE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16898820 ↗MalfunctionMar 15, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REPORTED INCIDENT: THE SAFETY, ALTHOUGH ENGAGED, DID NOT SLIDE ALL THE WAY DOWN TO THE END OF THE NEEDLE. THUS LEAVING THE TIP OF THE NEEDLE EXPOSED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16544525 ↗MalfunctionFeb 10, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: SAFETY DEVICE DID NOT DEPLOY & HAD RESISTANCE WHEN PULLING OUT THE NEEDLE FROM THE CATHETER. THE SAFETY DEVICE WAS STUCK IN THE MIDDLE OF THE NEEDLE. NO INJURY REPORTED. POTENTIAL LOT NUMBERS PROVIDED: LOT NUMBER 22C29G8932 - PRODUCTION DATE 03/29/2022; EXPIRY DATE 03/01/2027. LOT NUMBER 22D04G8932 - PRODUCTION DATE 04/04/2022; EXPIRY DATE 04/01/2027. LOT NUMBER 22F26G8952 - PRODUCTION DATE 06/26/2022; EXPIRY DATE 06/01/2027. LOT NUMBER 22D24G8936 - PRODUCTION DATE 04/24/2022; EXPIRY DATE 04/01/2027.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16350415 ↗MalfunctionNov 23, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: PLACED CATHETER AND BLOOD BACKED UP AND OUT OF HUB, BLOOD CONTROL VALVE FAILURE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15853950 ↗MalfunctionNov 2, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE 20G, CATHLON NEEDLE. IT SEEMS THAT THE NEEDLE ON THE CATHLON, STUCK OUT "QUITE A WAY OUTSIDE THE SAFETY LOCK AREA," AND THERE WAS A STICK. TWO POTENTIAL LOT NUMBERS REPORTED: 21L15G8933 (EXP 10/1/26). 22B20G8932 (EXP 2/1/27).
Patient problems: Needle Stick/Puncture
MAUDE report 15713359 ↗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 12604877 ↗MalfunctionApr 23, 2021Leak/Splash; Leak/Splash
AS REPORTED BY USER FACILITY: EVENT 1 BLOOD LEAKING FROM PIVC HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11719861 ↗MalfunctionApr 23, 2021Leak/Splash; Leak/Splash
AS REPORTED BY USER FACILITY: EVENT 2: BLOOD LEAKING FROM PIVC HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11719820 ↗MalfunctionApr 23, 2021Leak/Splash; Leak/Splash
AS REPORTED BY USER FACILITY: EVENT 1: BLOOD LEAKING FROM PIVC HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11719796 ↗MalfunctionApr 23, 2021Leak/Splash; Leak/Splash
AS REPORTED BY USER FACILITY: EVENT 2. BLOOD LEAKING FROM PIVC HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11719772 ↗
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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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