INTROCAN SAFETY® 4252560-020Recalls & reported problems
B. Braun Medical Inc. · INTROCAN SAFETY FEP 18G, 1.3X32MM-US · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964398858), received between Jul 1, 2022 and Jul 1, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
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.
Most reported problems
Device problems
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN "AIR CAME IN FROM THE CONNECTION." " THERE WAS A REPORT THAT AIR WAS MIXED IN FROM THE INFUSION CONNECTION PART. THE SAMPLE WILL BE SENT WITH THE TOP EXTENSION TUBE CONNECTED. THE SAME EVENT HAS BEEN REPORTED BEFORE (LOT21G04G8373 / CC400556698). THIS TIME, WE WILL SEND SAMPLES FOR 1 USED AND 2 UNOPENED, A TOTAL 3 PCS. PLEASE ALSO INVESTIGATE UNOPENED PRODUCTS. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIEN: NONE. SAMPLE: AVAILABLE, WILL BE SHIPPED LATER. BATCH: 21G04G8373."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14888640 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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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