Introcan Safety ® 2 4232006-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety 2 - 20G x 1.0 in., PUR, Straight · Class 2
All models of Introcan Safety 2 (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04046955341894), received between Feb 22, 2023 and Jan 16, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (7 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 Problem7
- Break5
- Fail-Safe Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Needle Stick/Puncture2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION DEFECTIVE IV CATHETERS DETAILED INQUIRY DESCRIPTION CLINICIANS NOTED ON THE IV CATHETERS THAT THERE IS A "COATING" ON IT. WAS DESCRIBED AS "WAXY" OR A "FILM" ON THE CATHETER. OTHERS DESCRIBED AS A "BALL" LIKE SUBSTANCE APPEARING ON THE CATHETERS. SOME NOTED THE COATING BEFORE PLACING THE IV. OTHERS WERE NOTED WHEN PLACED IN THE PATIENTS. SOME CLINICIANS STATED THAT WHEN THE CATHETER WAS THREADED INTO THE PATIENT, THE COATING GATHERED AT THE SITE OF INSERTION. DESCRIPTION OF THE PATIENT EVENT WHEN THREADING THE IV CATHETER, THE CLINICIAN NOTED THE FILM SUBSTANCE GATHERING AT THE INSERTION SITE OF THE CATHETER. AS IF THE FILM WAS COMING OFF THE CATHETER WHEN IT WAS INSERTED AND WAS GATHERING AT THE INSERTION SITE.
Patient problems: Needle Stick/Puncture
MAUDE report 18518422 ↗MalfunctionJan 16, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION DEFECTIVE IV CATHETERS DETAILED INQUIRY DESCRIPTION CLINICIANS NOTED ON THE IV CATHETERS THAT THERE IS A "COATING" ON IT. WAS DESCRIBED AS "WAXY" OR A "FILM" ON THE CATHETER. OTHERS DESCRIBED AS A "BALL" LIKE SUBSTANCE APPEARING ON THE CATHETERS. SOME NOTED THE COATING BEFORE PLACING THE IV. OTHERS WERE NOTED WHEN PLACED IN THE PATIENTS. SOME CLINICIANS STATED THAT WHEN THE CATHETER WAS THREADED INTO THE PATIENT, THE COATING GATHERED AT THE SITE OF INSERTION. DESCRIPTION OF THE PATIENT EVENT WHEN THREADING THE IV CATHETER, THE CLINICIAN NOTED THE FILM SUBSTANCE GATHERING AT THE INSERTION SITE OF THE CATHETER. AS IF THE FILM WAS COMING OFF THE CATHETER WHEN IT WAS INSERTED AND WAS GATHERING AT THE INSERTION SITE.
Patient problems: Needle Stick/Puncture
MAUDE report 18518420 ↗MalfunctionNov 15, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: CATHETER SHEARING IS2 ITEM # 4232006-02, LOT # 22N01G8271. EMAIL RECEIVED FROM CUSTOMER ON 09OCT2023 REGARDING CLARIFICATION ON COMPLAINT DESCRIPTION: "THE CATHETERS HAD EXTRA COATING. FOUR CATHETERS WERE IDENTIFIED." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145037 ↗MalfunctionNov 15, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: CATHETER SHEARING IS2 ITEM # 4232006-02, LOT # 22N01G8271. EMAIL RECEIVED FROM CUSTOMER ON 09OCT2023 REGARDING CLARIFICATION ON COMPLAINT DESCRIPTION: "THE CATHETERS HAD EXTRA COATING. FOUR CATHETERS WERE IDENTIFIED." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145032 ↗MalfunctionNov 15, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 3: DETAILED INQUIRY DESCRIPTION: CATHETER SHEARING IS2 ITEM # 4232006-02, LOT # 22N01G8271. EMAIL RECEIVED FROM CUSTOMER ON 09OCT2023 REGARDING CLARIFICATION ON COMPLAINT DESCRIPTION: "THE CATHETERS HAD EXTRA COATING. FOUR CATHETERS WERE IDENTIFIED." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145031 ↗MalfunctionNov 15, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 4: DETAILED INQUIRY DESCRIPTION: CATHETER SHEARING IS2 ITEM # 4232006-02, LOT # 22N01G8271. EMAIL RECEIVED FROM CUSTOMER ON 09OCT2023 REGARDING CLARIFICATION ON COMPLAINT DESCRIPTION: "THE CATHETERS HAD EXTRA COATING. FOUR CATHETERS WERE IDENTIFIED." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145030 ↗MalfunctionNov 15, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: IS2 PASSIVE SAFETY DID NOT ENGAGE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144985 ↗MalfunctionOct 11, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER REPORTED CATHETER SHEARING AND CATHETERS HAD EXTRA COATING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17911925 ↗MalfunctionFeb 22, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION - BLOOD CONTROL FEATURE DID NOT WORK. DETAILED INQUIRY DESCRIPTION - NURSE WAS USING IS2 PRODUCT TO START IV. UPON REMOVING THE NEEDLE, THE BLOOD CONTROL FEATURE DID NOT WORK, AND BLOOD POURED OUT OF THE HUB AS IF IT WAS NOT A BLOOD CONTROL PRODUCT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16418853 ↗
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page