INTROCAN SAFETY® 4252560-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 18 Ga. x 1.25 in., FEP, Straight · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046963165901), received between Mar 27, 2019 and Jun 7, 2024 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (5 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 Problem5
- Break3
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient3
- Needle Stick/Puncture1
- Pain1
- Swelling/ Edema1
- Thrombosis/Thrombus1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: INTROCAN SAFETY FAILED TO ACTIVATE AND CLINICIAN WAS STUCK. DETAILED INQUIRY DESCRIPTION: CLINICIAN IN ED WAS STARTING IV AND THE CLIP DID NOT ATTACH TO NEEDLE TIP AND CLINICIAN WAS STUCK IN THE FIGURE BY NEEDLE TIP
Patient problems: Needle Stick/Puncture
MAUDE report 19488791 ↗MalfunctionJul 6, 2023Difficult to Remove; Fail-Safe Problem; Difficult to Remove; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: PER MEDWATCH NUMBER 4900320000-2023-8016: "THE PROVIDER WAS ESTABLISHING IV ACCESS. ONCE THE FLASH CHAMBER FILLED, THE PROVIDER TRIED TO GET THE CATHETER TO DISLODGE FROM THE NEEDLE WHICH WAS UNSUCCESSFUL. THE PROVIDER ALSO ATTEMPTED TO RETRACT THE NEEDLE AND THE NEEDLE WOULD NOT RETRACT WHILE IN THE VEIN OR WHEN THE NEEDLE WAS PULLED OUT OF THE VEIN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17275297 ↗MalfunctionOct 21, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SAFETY MECHANISM FAILED TO DEPLOY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15652248 ↗MalfunctionAug 22, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE MOST RECENT INCIDENT OCCURRED AUGUST 6TH WHEN A MEDIC WAS USING THE 18GA CATHETER AND THE SAFETY CLIP FAILED TO FULLY ENGAGE. THIS RESULTED IN THE NEEDLE PUNCTURING A GLOVE BUT DID NOT BREAK THE SKIN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15265076 ↗MalfunctionFeb 25, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: SAFETY FEATURE ON NEEDLES DOES NOT WORK PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13599996 ↗MalfunctionJan 11, 2022Break; Break
AS REPORTED BY THE USER FACILITY: MEDWATCH FORM RECEIVED TO MEDICAL AFFAIRS ON 21DEC2021. BRAUN INTROCAN INTRAVENOUS CATHETER 18 GAUGE INSERTED LEFT FOREARM [DATE ENCRYPTED]. PATIENT DISCHARGED ON [DATE ENCRYPTED] 2021. PATIENT PRESENTED ON [DATE ENCRYPTED] 2021 AT 17:29 WITH LEFT FOREARM PAIN AND SWELLING, NO DRAINAGE, NO INDURATION. OR ABSCESS. PATIENT WAS AFEBRILE, NO RASH, AND NO ADENOPATHY. ON [DATE ENCRYPTED] 2021: OCCLUSIVE SUPERFICIAL VENOUS THROMBOSIS IN THE SUPERFICIAL VEIN OF THE LEFT FOREARM ASSOCIATED WITH THE VENOUS CATHETER. NO DEEP VEIN THROMBOSIS NOTED. ON [DATE ENCRYPTED]: NO DEEP VEIN THROMBOSIS SEEN. SUPERFICIAL VENOUS THROMBUS IS PRESENT. ARTIFACT WITHIN THE THROMBUS SUGGESTING A RETAINED CATHETER MAY REPRESENT CASTING ARTIFACT.
Patient problems: Foreign Body In Patient; Pain; Swelling/ Edema; Thrombosis/Thrombus
MAUDE report 13228783 ↗MalfunctionOct 8, 2019Break; Break
AS REPORTED BY USER FACILITY: TIP OF SHEATH BROKE OFF INSIDE THE PATIENT WHILE STARTING THE IV. THE PATIENT WAS DISCHARGED HOME. THE PRODUCT WAS NOT RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 9167126 ↗InjuryMar 27, 2019Break; Break
AS REPORTED BY USER FACILITY: THE PATIENT HAD THE IV IN THEIR AC (NOT SURE WHICH ARM) AND THE CATHETER PORTION BROKE OFF IN THE VEIN. THIS PATIENT HAD TO GO TO SURGERY TO HAVE THE CATHETER PORTION REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 8457975 ↗
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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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