INTROCAN SAFETY® 4251644-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 20 Ga. x 1.25 in., PUR, Straight · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Introcan Safety IV catheter has 23 reports naming its identifier, mostly describing the needle's safety shield failing to deploy, leaving needle tips exposed and sometimes causing needle sticks to staff; a few reports mention the catheter breaking or leaking, including fragments left in a patient's arm. There were no deaths and 1 injury. No recalls name this device. Reports fell from 6 in the earlier 12-month period to 1 in the most recent.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04046963166007), received between Jul 10, 2018 and Dec 19, 2025 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (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
- Fail-Safe Problem15
- Break5
- Device Handling Problem2
- Use of Device Problem2
- Activation Problem1
- Leak/Splash1
- Material Puncture/Hole1
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Needle Stick/Puncture6
- Foreign Body In Patient3
- Granuloma1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem
AS REPORTED BY THE USER FACILITY: DURING THERAPY THE IV CATHETER SAFETY SHIELD DID NOT DEPLOY. CLINICIAN WAS POKED WITH A DIRTY NEEDLE.
Patient problems: Needle Stick/Puncture
MAUDE report 23854838 ↗MalfunctionMar 6, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: FAULTY IV CATHETER. WITH IV INSERTION BLOOD WAS NOTED TO BE LEAKING NEAR WHERE CLEAR CATHETER AND PINK HUB CONNECT. UPON FLUSHING IV WITH SALINE, SMALL HOLE NOTED TO CLEAR CATHETER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540476 ↗InjuryFeb 24, 2025Break; Break
ACCORDING TO THE EVENT DESCRIPTION: CLIENT UNDERWENT SURGERY AT (B)(6) ON (B)(6) 2023 AND WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2023. CLIENT CONSULTED THE ANGIOLOGY AND VASCULAR SURGERY DEPARTMENT AT THE (B)(6) DUE TO A NODULAR FORMATION ON THE LEFT ARM. THE (B)(6) MEDICAL REPORT REFERRED TO THE PRESENCE OF A FOREIGN BODY, HIGHLY SUGGESTIVE OF A FRAGMENT OF AN INTRAVENOUS CATHETER. EXCISION WAS CARRIED OUT AT (B)(6) ON (B)(6)2024 AND THE NATURE OF THE MATERIAL, APPROXIMATELY 5MM LONG, WAS CONFIRMED.
Patient problems: Granuloma
MAUDE report 21449432 ↗MalfunctionFeb 19, 2025Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY UF/IMPORTER REPORT # (B)(4): DESCRIBE THE EVENT OR PROBLEM: EMERGENCY DEPARTMENT (ED) REGISTERED NURSE (RN) WAS PLACING PERIPHERAL INTRAVENOUS ACCESS LINE (PIV) IN PATIENT. AFTER SUCCESSFUL PIV ACCESS WAS OBTAINED, RN REMOVED NEEDLE AND ATTEMPTED TO DEPLOY NEEDLE SAFETY MECHANISM. SAFETY ONLY DEPLOYED 1/3 OF THE WAY UP THE NEEDLE. NO INJURY REPORTED TO PATIENT OR RN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413988 ↗MalfunctionNov 13, 2024Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INTROCAN SAFETY® INTRAVENOUS (IV) CATHETER (MATERIAL # 4251644-02, LOT # 0061928058) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, WHEN THE NEEDLE WAS RETRACTED, THE PASSIVE SAFETY MECHANISM FAILED TO ENGAGE. REPORTEDLY, THE TIP OF THE NEEDLE REMAINED EXPOSED INSTEAD OF BEING SAFEGUARDED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672748 ↗MalfunctionNov 13, 2024Fail-Safe Problem; Fail-Safe Problem
EVENT 3: IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INTROCAN SAFETY® INTRAVENOUS (IV) CATHETER (MATERIAL # 4251644-02, LOT # 0061928058) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, WHEN THE NEEDLE WAS RETRACTED, THE PASSIVE SAFETY MECHANISM FAILED TO ENGAGE. REPORTEDLY, THE TIP OF THE NEEDLE REMAINED EXPOSED INSTEAD OF BEING SAFEGUARDED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672728 ↗MalfunctionNov 13, 2024Fail-Safe Problem; Fail-Safe Problem
EVENT 1 IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INTROCAN SAFETY® INTRAVENOUS (IV) CATHETER (MATERIAL # 4251644-02, LOT # 0061928058) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2024. ACCORDING TO THE COMPLAINANT, WHEN THE NEEDLE WAS RETRACTED, THE PASSIVE SAFETY MECHANISM FAILED TO ENGAGE. REPORTEDLY, THE TIP OF THE NEEDLE REMAINED EXPOSED INSTEAD OF BEING SAFEGUARDED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672688 ↗MalfunctionOct 11, 2024Fail-Safe Problem; Fail-Safe Problem
AS REPORTED, EVENT 1 WE HAVE HAD TWO IVS NOW THAT THE SAFETY HAS NOT DEPLOYED WHEN REMOVING THE NEEDLE FROM THE CATHETER.
Patient problems: Needle Stick/Puncture
MAUDE report 20428059 ↗MalfunctionOct 11, 2024Fail-Safe Problem; Fail-Safe Problem
AS REPORTED, EVENT 2: WE HAVE HAD TWO IVS NOW THAT THE SAFETY HAS NOT DEPLOYED WHEN REMOVING THE NEEDLE FROM THE CATHETER.
Patient problems: Needle Stick/Puncture
MAUDE report 20427996 ↗MalfunctionOct 10, 2024Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY USER FACILITY, SAFETY DID NOT WORK CORRECTLY, NEEDLE WAS VERY DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416111 ↗MalfunctionOct 10, 2024Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY USER FACILITY, SAFETY DID NOT WORK CORRECTLY, NEEDLE WAS VERY DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416004 ↗MalfunctionOct 8, 2024Fail-Safe Problem; Fail-Safe Problem
AS REPORTED, EVENT 3. INTROCAN SAFETY SHIELD DIDN'T ENGAGE ON 3 CATHETERS . AL INTROCAN SAFETY. ALL 20 GAUGE. 2 DIFFERENT PEOPLE IN ED ON 2 CONSECUTIVE DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20400862 ↗MalfunctionOct 8, 2024Use of Device Problem; Fail-Safe Problem; Use of Device Problem; Fail-Safe Problem
AS REPORTED, EVENT 2: INTROCAN SAFETY SHIELD DIDN'T ENGAGE ON 3 CATHETERS. AL INTROCAN SAFETY. ALL 20 GAUGE. 2 DIFFERENT PEOPLE IN ED ON 2 CONSECUTIVE DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20400837 ↗MalfunctionOct 8, 2024Use of Device Problem; Fail-Safe Problem; Use of Device Problem; Fail-Safe Problem
AS REPORTED, EVENT 1: INTROCAN SAFETY SHIELD DIDN'T ENGAGE ON 3 CATHETERS. AL INTROCAN SAFETY. ALL 20 GAUGE. 2 DIFFERENT PEOPLE IN ED ON 2 CONSECUTIVE DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20400632 ↗MalfunctionJul 17, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SAFETY ON INTROCAN SAFETY IV CATHETER DIDN'T ACTIVATE PROPERLY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15036890 ↗MalfunctionApr 4, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE NEEDLE WAS FOUND WITH NO SAFETY SHIELD COVERING THE TIP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13994496 ↗MalfunctionFeb 26, 2021Break; Break
AS REPORTED BY USER FACILITY: UPON REMOVAL IV CATHETER WAS DAMAGED AND APPEARED SHORTER IN LENGTH APPROX 1CM IN LENGTH UPON REMOVAL. NURSING STAFF HAD CONCERN CATHETER SHEERED INSIDE THE PATIENT AND A ULTRASOUND WAS PERFORMED TO VERIFY. ULTRASOUND SHOWED THAT THERE WAS NO CATHETER SHEER OR REMNANTS OF THE CATHETER INSIDE THE VASCULATURE OF THE PATIENT. THE PATIENT ALSO HAD A FOLLOW UP CT SCAN AND IT DID NOT SHOW ANYTHING. THE PATIENT HAD NO DEFICITS AND WAS DISCHARGED HOME.
Patient problems: Foreign Body In Patient
MAUDE report 11386639 ↗MalfunctionJan 19, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem
AS REPORTED BY THE USER FACILITY: "A NURSE STARTED AN IV AND IT DID NOT WORK. THE SAFETY CLIP DEPLOYED. WHILE CLEANING UP, THE NURSE WAS STUCK IN THE FINGER BY THE NEEDLE."
Patient problems: Needle Stick/Puncture
MAUDE report 11196287 ↗MalfunctionNov 4, 2019Break; Break
AS REPORTED BY THE USER FACILITY: "A CATHETER BROKE WHEN BEING REMOVED FROM A PATIENT. THE CATHETER WAS COMPLETELY REMOVED FROM THE PATIENT USING THE NORMAL TECHNIQUE OF REMOVING CATHETERS BY APPLYING PRESSURE TO THE VEIN. WHEN THE CATHETER WAS REMOVED, IT WAS NOTICED THAT THE CATHETER WAS BROKEN. THE PATIENT WAS SAFELY CANALIZED IN ANOTHER VEIN IN THE OTHER ARM."
Patient problems: Foreign Body In Patient
MAUDE report 9273676 ↗MalfunctionOct 18, 2019Break; Break
AS REPORTED BY THE USER FACILITY: A CATHETER BROKE WHEN BEING REMOVED FROM A PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 9210682 ↗MalfunctionSep 10, 2019Break; Break
AS REPORTED BY THE USER FACILITY: "NURSE IN THE ED STARTED AN IV, AT THE TIME OF STYLET REMOVAL, THE NURSE SUSTAINED AN ABRASION TO HER HAND WHEN A PIECE OF METAL FLEW OFF THE STYLET AND SCRAPPED HER HAND. THE SAFETY CLIP WAS INTACT PER THE CUSTOMER." NO PATIENT INJURY REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 8983410 ↗MalfunctionApr 18, 2019Protective Measures Problem; Protective Measures Problem
AS REPORTED ON MEDWATCH MW5085415: UPON WITHDRAWING THE NEEDLE, IT WAS NOTED THE PROTECTIVE LOCKING MECHANISM DID NOT PROPERLY COVER THE NEEDLE END.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8527714 ↗MalfunctionJul 10, 2018Activation Problem; Activation Problem
AS REPORTED BY THE USER FACILITY: THE RN SUCCESSFULLY INSERTED IV CATHETER. WHEN HE PULLED THE NEEDLE OUT, THE SAFETY FEATURE DID NOT ENGAGE AND HE STUCK HIMSELF WITH A CONTAMINATED NEEDLE. NO INFORMATION PROVIDED ON USER INJURY AND/OR TREATMENT REQUIRED. NO INJURY TO PATIENT.
Patient problems: Needle Stick/Puncture
MAUDE report 7673326 ↗
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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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