INTROCAN SAFETY® 4251652-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 20 Ga. x 1 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 is a short-term tube placed in a vein for fluids or medicine. The 33 reports mostly mention the safety shield not covering the needle, contamination in or on the catheter, and the catheter breaking inside a patient's arm. There are no deaths and 1 injury. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04046963185206), received between Dec 2, 2016 and Mar 19, 2026 — classified as 1 injury, 32 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (11 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
- Contamination /Decontamination Problem11
- Fail-Safe Problem8
- Break7
- Activation, Positioning or Separation Problem2
- Leak/Splash2
- Positioning Failure2
- Protective Measures Problem2
- Fail-Safe Design Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient11
- Needle Stick/Puncture7
- No Consequences Or Impact To Patient3
- Exposure to Body Fluids1
- Foreign Body In Patient1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: NURSE STATED - WHEN SHE PULLED THE CATHETER OUT, SHE NOTICED THE PASSIVE SAFETY SHIELD WAS NOT SECURE ON THE TOP OF THE CATHETER AND THE NEEDLE TIP WAS EXPOSED. SHE SAID THE PASSIVE SAFETY SHIELD WAS MOVING UP AND DOWN THE CATHETER. PHOTO UPLOADED IN FILES SECTION. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637388 ↗MalfunctionJun 2, 2025Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION NEEDLE STICK INJURY. DETAILED INQUIRY DESCRIPTION NURSE WAS PLACING INTROCAN SAFETY 2 IN SHARPS CONTAINER WHEN SHE FELT AS IF SHE GOT "STUCK" BY THE NEEDLE. UPON LOOKING AT THE NEEDLE, IT WAS STICKING OUT PAST THE SAFETY SHIELD AND THE NURSE DID IN FACT GET STUCK ON HER RIGHT INDEX FINGER. OCCURRENCE ONLY HAPPENED ONE TIME AND SPECIMEN IS STILL ON SITE. REPORT FROM CUSTOMER AND CONFIRMED ON (B)(6) 2025 - "A FINGERSTICK TO RIGHT INDEX FINGER WAS REPORTED TO THE IC RN. THE NURSE WAS STANDING AT THE PACU NURSING COUNTER AND WAS TESTING A PATIENTS FSBS AT THE GLUCOMETER STATION. SHE WENT TO THE SHARPS CONTAINER AND A COWORKER HEARD HER SAY, "I'M PRETTY SURE I JUST STUCK MYSELF". THE IC NURSE JOINED HER AT THE SINK UNDER THE SHARPS CONTAINER AND ASSESSED HER GLOVED HAND FOR A PUNCTURE HOLE. NO HOLE WAS NOTED. SHE REMOVED THE GLOVE AND A SMALL SPOT OF BLOOD WAS ON HER FINGER WHERE HER SKIN WAS PUNCTURED."
Patient problems: Needle Stick/Puncture
MAUDE report 22126668 ↗MalfunctionNov 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: DEFECTIVE INTROCAN IV CATHETER. DETAILED INQUIRY DESCRIPTION: CUSTOMER RECEIVED INTROCAN PRODUCT THAT HAD BLACK PARTICLES INSIDE THE CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663581 ↗InjuryDec 18, 2023Break; Break
AS REPORTED BY THE USER FACILITY: CATHETER BROKEN OFF. DESCRIPTION - PIECE OF THE CATHETER BROKE OFF IN THE PATIENTS ARM AND HAD BEEN SURGICALLY REMOVED. PATIENT WAS ADMITTED TO THE HOSPITAL 8/18/2023 WHICH IV WAS STARTED. ON (B)(6) 2023 IV WAS REMOVED. ONCE PATIENT WAS RELEASED FROM HOSPITAL, HE WAS SENT HOME AND THE PLACE THE IV WAS GOT INFECTED. THEY HAD AN ULTRASOUND DONE AND FOUND A PIECE OF THE CATHETER IN HIS BASILIC VEIN (RIGHT ARM). ON (B)(6) 2023 SURGERY WAS PERFORMED TO REMOVE THE BROKEN PIECE. PATIENT WAS OKAY. MALE 61. UNABLE TO VERIFY WHICH CATHETER BROKE OFF. PART NUMBERS LISTED ARE 4252527-02 & 4251652-02 IN PATIENT RECORD.
Patient problems: Foreign Body In Patient; Unspecified Infection
MAUDE report 18347165 ↗MalfunctionDec 6, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER SWITCHED FROM IS TO IS2. DURING THE CONVERSION, THE ORIGINAL INTROCAN WAS PULLED, BUT THERE IS STILL PRODUCT IN AREAS NOT UNCOVERED. THE NURSES COMMENTED THAT WITHOUT AN OBVIOUS PACKAGE DISTINCTION, THEY DON'T ALWAYS KNOW THAT THEY ARE USING IS AND NOT IS2 SO THEY DON'T OCCLUDE RESULTING IN A BLOODY MESS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15928861 ↗MalfunctionAug 12, 2022Break; Break
AS REPORTED BY THE USER FACILITY: EVENT 3: DETAILED INQUIRY DESCRIPTION - CUSTOMER REPORTS A TOTAL OF 5 INCIDENCE FROM MULTIPLE CLINICIANS OF SHEERED CATHETER. NO INJURY REPORTED. TWO POSSIBLE LOT NUMBERS PROVIDED. LOT 21M27G8361; EXPIRY DATE 11/01/2026; PRODUCTION DATE 11/27/2021. LOT 21N29G8392; EXPIRY DATE 12/01/2026; PRODUCTION DATE 12/29/2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217537 ↗MalfunctionAug 12, 2022Break; Break
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION - CUSTOMER REPORTS A TOTAL OF 5 INCIDENCE FROM MULTIPLE CLINICIANS OF SHEERED CATHETER. NO INJURY REPORTED. TWO POSSIBLE LOT NUMBERS PROVIDED: LOT 21M27G8361; EXPIRY DATE 11/01/2026; PRODUCTION DATE 11/27/2021; LOT 21N29G8392; EXPIRY DATE 12/01/2026; PRODUCTION DATE 12/29/2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217511 ↗MalfunctionAug 12, 2022Break; Break
AS REPORTED BY THE USER FACILITY: EVENT 4: DETAILED INQUIRY DESCRIPTION - CUSTOMER REPORTS A TOTAL OF 5 INCIDENCE FROM MULTIPLE CLINICIANS OF SHEERED CATHETER. NO INJURY REPORTED. TWO POSSIBLE LOT NUMBERS PROVIDED LOT 21M27G8361; EXPIRY DATE 11/01/2026; PRODUCTION DATE 11/27/2021. LOT 21N29G8392; EXPIRY DATE 12/01/2026; PRODUCTION DATE 12/29/2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217506 ↗MalfunctionAug 12, 2022Break; Break
AS REPORTED BY THE USER FACILITY: EVENT 5: DETAILED INQUIRY DESCRIPTION - CUSTOMER REPORTS A TOTAL OF 5 INCIDENCE FROM MULTIPLE CLINICIANS OF SHEERED CATHETER. NO INJURY REPORTED. TWO POSSIBLE LOT NUMBERS PROVIDED: LOT 21M27G8361; EXPIRY DATE 11/01/2026; PRODUCTION DATE 11/27/2021; LOT 21N29G8392; EXPIRY DATE 12/01/2026; PRODUCTION DATE 12/29/2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217504 ↗MalfunctionAug 12, 2022Break; Break
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION - CUSTOMER REPORTS A TOTAL OF 5 INCIDENCE FROM MULTIPLE CLINICIANS OF SHEERED CATHETER. NO INJURY REPORTED. TWO POSSIBLE LOT NUMBERS PROVIDED LOT 21M27G8361; EXPIRY DATE 11/01/2026; PRODUCTION DATE 11/27/2021. LOT 21N29G8392; EXPIRY DATE 12/01/2026; PRODUCTION DATE 12/29/2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217502 ↗MalfunctionApr 27, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EMPLOYEE INJURY LAST NIGHT. RN WAS CHANGING OUT A 20 GAUGE IV CATHETER THAT WAS LEAKING AROUND THE HUB, CATH STARTED SEPARATING AROUND THE HUB. BLOOD EXPOSURE TO THE EYE.
Patient problems: Exposure to Body Fluids
MAUDE report 14218623 ↗MalfunctionJan 21, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: EVENT 3: WHEN WITHDRAWING THE NEEDLE THE SAFETY MECHANISM BLOCKED, FORCING THE NURSES TO COMPLETELY WITHDRAW THE DAVP FROM THE VEIN. THIS PROBLEM OCCURED THREE DIFFERENT TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314948 ↗MalfunctionJan 21, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: EVENT 1. WHEN WITHDRAWING THE NEEDLE THE SAFETY MECHANISM BLOCKED, FORCING THE NURSES TO COMPLETELY WITHDRAW THE DAVP FROM THE VEIN. THIS PROBLEM OCCURED THREE DIFFERENT TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314946 ↗MalfunctionJan 21, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: EVENT 2. WHEN WITHDRAWING THE NEEDLE THE SAFETY MECHANISM BLOCKED, FORCING THE NURSES TO COMPLETELY WITHDRAW THE DAVP FROM THE VEIN. THIS PROBLEM OCCURED THREE DIFFERENT TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314945 ↗MalfunctionJan 7, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: EVENT 2. THREE TIMES IN A ROW, WHEN PULLING OUT THE NEEDLE, THE MECHANISM LOCK GETS BLOCKED.
Patient problems: Needle Stick/Puncture
MAUDE report 13196353 ↗MalfunctionJan 7, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: EVENT 3. THREE TIMES IN A ROW, WHEN PULLING OUT THE NEEDLE, THE MECHANISM LOCK GETS BLOCKED.
Patient problems: Needle Stick/Puncture
MAUDE report 13196310 ↗MalfunctionJan 7, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: EVENT 1, THREE TIMES IN A ROW, WHEN PULLING OUT THE NEEDLE, THE MECHANISM LOCK GETS BLOCKED.
Patient problems: Needle Stick/Puncture
MAUDE report 13196295 ↗MalfunctionSep 12, 2019Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: THE METAL SAFETY PART ON THE NEEDLE DID NOT ENGAGE COMPLETELY WHEN REMOVED, LEAVING A SHARP TIP EXPOSED. THE NURSE WAS STUCK AS A RESULT.
Patient problems: Needle Stick/Puncture
MAUDE report 9009476 ↗MalfunctionAug 15, 2019Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: THE NEEDLE STUCK THE EMPLOYEE IN THE HAND DURING DISPOSAL, AT THE TIME SHE NOTED THE SAFETY MECHANISM WAS NO LONGER COVERING THE TIP OF THE NEEDLE.
Patient problems: Needle Stick/Puncture
MAUDE report 8897222 ↗MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 10. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8427987 ↗MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 8. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8427986 ↗MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 7. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8427985 ↗MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 9. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8427984 ↗MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 4: CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8427983 ↗MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2: CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8427982 ↗
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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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