INTROCAN SAFETY® 4252520-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 22 Ga. x 1.75 in., FEP, Straight · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046963318178), received between Mar 1, 2019 and Jun 28, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Fail-Safe 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
- Fail-Safe Problem3
- Break2
- Contamination /Decontamination Problem1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Blood Loss1
- Foreign Body In Patient1
- Needle Stick/Puncture1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REPORTER CALLED TO REPORT - SAFETY MECHANISM DIDN'T ENGAGE AND BROKE OFF INTO THE CATHETER HUB. REMAINED IN THE CATHETER HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639102 ↗MalfunctionJun 19, 2024Break; Break
AN UNANNOUNCED SAMPLE ARRIVED THAT WAS ORIGINALLY FOR COMPLAINT PIR (B)(4). AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: PROBLEMS WITH CATHETERS SHEARED WHEN COMING OUT OF PACKAGE. DETAILED INQUIRY DESCRIPTION: CRT AND I (EMILY FROM VASCULAR ACCESS) WERE USING 22G 1.75 INCH CATHETERS TO PLACE ULTRASOUND IVS IN MULTIPLE PATIENTS DURING THE MORNING OF (B)(6) 2021. ON MULTIPLE OCCASIONS, INCLUDING THE MOST NOTICEABLE INCIDENT WITH THE PATIENT STATED IN THE REPORT, THE CATHETER WOULDN'T ADVANCE FROM THE NEEDLE AND WAS CAUSING PAIN TO THE PATIENTS UPON INSERTION. SO, WE REMOVED IT AND FOUND THE CATHETER TO BE SHEARED. THIS HAPPENED 3 TIMES USING THE 22G 1.75 INCH CATHETERS ON MULTIPLE PATIENTS. I SAVED THE PACKAGE BUT NOT HE ACTUAL CATHETER DUE TO IT BEING A BIOHAZARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570080 ↗MalfunctionAug 12, 2022Fail-Safe Problem; Fail-Safe Problem
PER MEDWATCH (B)(4). SAFETY DEVICE FOR BRAUN INTROCAN SAFETY IV CATHETER DID NOT ENGAGE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15218362 ↗MalfunctionMay 16, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER WAS USING 4252520-02 INTROCAN SAFETY CATHETERS. UPON DRAWING THE STYLET OUT OF THE CATHETER, THE NEEDLE WAS EXPOSED, THE SAFETY CLIP DID NOT FUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14406969 ↗MalfunctionOct 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: SMALL WORM OR LARVAE IN CATHETER
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9167129 ↗MalfunctionJun 14, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: IMMEDIATELY HAD BLOOD COMING OUT OF PUNCTURE SITE. ATTEMPTED TO ASPIRATE BLOOD AND GOT AIR, ABLE TO HOLD DOWN SITE AND FLUSH AND ASPIRATE BLOOD. WITH SECOND FLUSH NOTED NS COMING OUT OF PUNCTURE SITE.
Patient problems: Blood Loss; Needle Stick/Puncture
MAUDE report 8699238 ↗InjuryMar 1, 2019Break; Break
AS REPORTED ON MEDWATCH MW5083446: UPON REMOVAL OF PERIPHERAL IV CATHETER IN THIS PATIENT'S LEFT ARM,THE CATHETER TIP WAS MISSING AND REMAINED IN PATIENT'S ARM. PATIENT NEEDED TO BE TAKEN TO THE OPERATING ROOM LATER THAT NIGHT TO HAVE THE CATHETER TIP REMOVED SURGICALLY, AND THIS WAS SUCCESSFUL. PATIENT DOING WELL AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 8383300 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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