Introcan Safety ® 2 4242012-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® 2 IV Catheter - 18 Ga. x 1.25 in. · 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 04046955746187), received between Dec 9, 2025 and Mar 3, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component4
- Contamination /Decontamination Problem3
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Hemorrhage/Blood Loss/Bleeding3
- Exposure to Body Fluids1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: THE INTERNAL FLANGE CAME OUT WITH THE STYLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498020 ↗MalfunctionMar 3, 2026Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: CUSTOMER STATED, "WHEN DR. (B)(6) WAS PLACING B. BRAUN INTROCAN SAFETY 2 IV (18G X 1.25") IN PATIENT AND PULLED BACK NEEDLE, PIECE OF THE OVER NEEDLE CANULA CAME OFF WITH THE SAFETY DEVICE." PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497920 ↗MalfunctionFeb 11, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: THE RN SUCCESSFULLY STARTED TWO SEPARATE IVS AND THE INTROCAN SAFETY 2 BLOOD CONTROL MECHANISM FAILED TO STOP THE BLOOD FROM FLOWING OUT OF THE HUB. THEY HAD TO CHANGE THE LINENS, AND THE NURSE WAS EXPOSED TO BLOOD. THE DATES AND TIMES ARE NOT CLEAR AS SHE REPORTED IT OCCURRED TWICE DURING THE PAST WEEK. THERE ARE NO SAMPLES ASIDE FROM THE PACKAGING OF ONE IV. PATIENT INJURY: NO.
Patient problems: Exposure to Body Fluids; Hemorrhage/Blood Loss/Bleeding
MAUDE report 24317336 ↗MalfunctionFeb 5, 2026Leak/Splash; Detachment of Device or Device Component
ACCORDING TO THE COMPLAINANT, THE IS2 CATHETER LEAKED BLOOD ALL OVER THE DRESSING AND OTHER SUPPLIES IN THE KIT. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24271705 ↗MalfunctionFeb 4, 2026Detachment of Device or Device Component
ACCORDING TO THE COMPLAINANT, THE SEPTUM DISLODGED AFTER TAKING OUT NEEDLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257373 ↗MalfunctionJan 13, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: THE BROWN LIQUID IN THE CATHETER HUB ISSUE CAN BE FOUND ON THE 4242012-2 (18 GA), THE 4242006-02, (20 GA) AND THE 4242004-2 (22 GA) CATHETER NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053131 ↗MalfunctionJan 12, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: THE BROWN LIQUID IN THE CATHETER HUB ISSUE CAN BE FOUND ON THE 4242012-2 (18 GA), THE 4242006-02, (20 GA) AND THE 4242004-2 (22 GA) CATHETER NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24040787 ↗MalfunctionJan 12, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: THE BROWN LIQUID IN THE CATHETER HUB ISSUE CAN BE FOUND ON THE 4242012-2 (18 GA), THE 4242006-02, (20 GA) AND THE 4242004-2 (22 GA) CATHETER NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24040483 ↗MalfunctionDec 9, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WHILE TROUBLESHOOTING, ONE NURSE MENTIONED THAT SHE HAD A SEPTUM THAT FAILED AND BLOOD CAME OUT OF THE HUB (THAT COMPLAINT HAS BEEN FILED). (B)(6) WAS THERE AND SAID SHE ALSO HAD AN 18G WHERE THE BLOOD CONTROL SEPTUM FAILED ALSO. SHE DID NOT HAVE ANY PRODUCT, PACKAGING OR PICTURES TO SHARE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23756720 ↗
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