INTROCAN SAFETY® 4253540-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 22 Ga. x 1 in., PUR, Winged · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046963318246), received between Sep 19, 2018 and Oct 10, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Protective Measures Problem3
- Fail-Safe Problem1
Patient problems
- No Consequences Or Impact To Patient2
- Needle Stick/Puncture1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2024Fail-Safe Problem; Fail-Safe Problem
ACCORDING TO THE COMPLAINT: " I WANTED TO INFUSE THE PATIENT, I HAD PUT ON MY GLOVES, I HAD NOT TAKEN A BOX ON MY TROLLEY, I LEFT TOWARDS THE CARE STATION WITH MY 3 CATHETERS IN MY HAND AND SECURED TO PUT THEM IN A NEEDLE BOX. THE SAFETY OF ONE OF THE CATHETERS WAS REMOVED AND I PRICKED MYSELF WITH THE CATHETER WITH WHICH I HAD TRIED TO INFUSE THE PATIENT." IMMEDIATE ACTIONS: HAND WASHING, 5-MINUTE DAKIN BATH AND ANALYSIS DONE BY NURSE HYGIENIST.
Patient problems: Pain
MAUDE report 20415755 ↗MalfunctionJan 13, 2020Protective Measures Problem; Protective Measures Problem
AS REPORTED ON MW5091486 RECEIVED FROM THE FDA: RN, AFTER INITIATING IV ACCESS IN A PATIENT, PLACED THE NEEDLE IN THE PLASTIC WRAP OFF TO THE SIDE WHILE SHE FINISHED SECURING THE IV. SHE THEN GRABBED THE PLASTIC WRAP WITH THE NEEDLE INSIDE TO DISCARD. THE SAFETY MECHANISM, ON THE TIP OF THE NEEDLE FAILED AND THE NEEDLE PUNCTURED THE PLASTIC WRAP AND FINGER. THE PATIENT WAS KNOWN TO HAVE HEPATITIS B AND C. THE PATIENT TESTED NEGATIVE FOR HIV.
Patient problems: Needle Stick/Puncture
MAUDE report 9582504 ↗MalfunctionSep 19, 2018Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: EVENT 1: THE SAFETY DEVICE DID NOT DEPLOY. .
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7890659 ↗MalfunctionSep 19, 2018Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: EVENT 2. THE SAFETY DEVICE DID NOT DEPLOY. .
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7890658 ↗
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- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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