INTROCAN SAFETY® 3 4251128-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04046964014017), received between Jun 15, 2018 and Jun 2, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 17, 2025Class IIOpen, Classified

   Increased risk for valve housing detachment causing leakage.

   Z-1397-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: UPON OPENING PACKAGE, CATHETER WAS BROKEN/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126518 ↗
• MalfunctionJun 2, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: WHILE PLACING THE CATHETER, THE IV NEEDLE WAS PARTIALLY PULLED BACK AND THEN REINSERTED. NEEDLE APPEARS SEPARATED/ SPLIT FROM THE CATHETER ITSELF. DETAILED INQUIRY DESCRIPTION: PRODUCT CODE: 4251128-02 EXPIRATION DATE: 1/1/30 LOT NUMBER: 25A04G8952. PATIENT WAS INVOLVED BUT CUSTOMER HAS NOT GOTTEN BACK WITH PATIENT INFORMATION TO FILE. DESCRIPTION OF THE PATIENT EVENT: IV PLACED, MINIMAL FLASH SEEN IN CHAMBER, ATTEMPTED TO CONTINUE PLACEMENT, CLIENT COMPLAINED OF PAIN, IV REMOVED, CATHETER SEEN SPLIT (APPEARED TO BE INTACT OTHERWISE/NO PIECES MISSING).

  Patient problems: Needle Stick/Puncture

  MAUDE report 22125746 ↗
• MalfunctionApr 24, 2025Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION INTROCAN SAFETY 3 SAFETY DID NOT COVER NEEDLE TIP DETAILED INQUIRY DESCRIPTION CUSTOMER HAS REPORTED THAT THE SAFETY SHEILD ON AN INTROCAN SAFETY 3 22G DID NOT COVER THE NEEDLE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898828 ↗
• MalfunctionJan 16, 2025Nonstandard Device; Nonstandard Device

  ACCORDING TO THE EVENT DESCRITPTION: THE DETAILS ARE AS FOLLOWS: STAFF REMOVED CANNULA OF PATIENT POST RECOVERING FROM ENDOSCOPIC PROCEDURES. WHEN DISPOSING THE USED CANNULA, SHE ACCIDENTALLY PRICKED HERSELF, NEEDLE STILL INTACT INSIDE THE CANNULA CATHETER. ADVISED STAFF TO CLEAN THE WOUND. ADVISED STAFF TO GO TO A&E - REFUSED. PATIENT RECORDS WERE CHECKED FOR ANY INFECTIOUS DISEASES - NON FOUND. PATIENT WAS ASKED IF SHE HAS HISTORY OF ANY INFECTIOUS DISEASES - NONE REPORTED. STAFF ADVISED THAT IF FEEL UNWELL TO BRING HERSELF TO A&E.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21167761 ↗
• MalfunctionJan 6, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 5. BRIEF INQUIRY DESCRIPTION IV CATHETER COMING APART. DETAILED INQUIRY DESCRIPTION: PER THE ACCOUNT "THE NURSES HAVE HAD ISSUES WITH A CERTAIN LOT # OF THE CLOSED CATH IV. THERE WERE I BELIEVE 4 THAT WERE USED AND I PULLED THE REST FROM SHELF. I HAVE 10 UNOPENED THAT I PULLED. THEY ARE COMING APART, WHICH IN TURN CAUSES PATIENTS TO BLEED." BASED ON INVESTIGATION RESULTS ON 06JAN2025, FIVE OUT OF TWELVE RETURNED SAMPLES WERE CONFIRMED. MDR 9610825-2025-00001 CREATED TO COVER FIFTH RECEIVED SAMPLE WITH CONFIRMED DEFECT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21082659 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: REPORTED ISSUE: WE ORDER OUR 22 GAUGE IVS THROUGH MED LINE AND NORMALLY DO NOT HAVE ISSUES. HOWEVER, THIS LAST ORDER OF THEM WE RECEIVED I BELIEVE 80% OR HIGHER OF THE BOX ARE DEFECTIVE. THE CATHETER PART OF THE IV IS WHAT IS SEEMING TO CAUSE MANY ISSUES WHEN STICKING PATIENTS AND ALSO CAUSING MULTIPLE STICKS TO BEFORE ONE IS SUCCESSFUL. IT IS ALMOST IMPOSSIBLE TO THREAD THE CATHETER THROUGH WITHOUT CAUSING DAMAGE AND DISCOMFORT TO THE VEIN. WE EVEN HAD THE CHAMBER OF ONE COME COMPLETELY OUT DURING INSERTION AND CAUSE BLEEDING FROM IT (WHEN THESE ARE SUPPOSED TO BE AUTO STOP). WE EVEN USED A DIFFERENT GAUGE FROM A LOCAL HOSPITAL AND EVERYTHING WORKED GREAT WITH IT (SAME BRAND). SO, I BELIEVE THIS WAS JUST A BAD BATCH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture; Pain; Perforation of Vessels

  MAUDE report 20461595 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3 REPORTED ISSUE: WE ORDER OUR 22 GAUGE IVS THROUGH MED LINE AND NORMALLY DO NOT HAVE ISSUES. HOWEVER, THIS LAST ORDER OF THEM WE RECEIVED I BELIEVE 80% OR HIGHER OF THE BOX ARE DEFECTIVE. THE CATHETER PART OF THE IV IS WHAT IS SEEMING TO CAUSE MANY ISSUES WHEN STICKING PATIENTS AND ALSO CAUSING MULTIPLE STICKS TO BEFORE ONE IS SUCCESSFUL. IT IS ALMOST IMPOSSIBLE TO THREAD THE CATHETER THROUGH WITHOUT CAUSING DAMAGE AND DISCOMFORT TO THE VEIN. WE EVEN HAD THE CHAMBER OF ONE COME COMPLETELY OUT DURING INSERTION AND CAUSE BLEEDING FROM IT (WHEN THESE ARE SUPPOSED TO BE AUTO STOP). WE EVEN USED A DIFFERENT GAUGE FROM A LOCAL HOSPITAL AND EVERYTHING WORKED GREAT WITH IT (SAME BRAND). SO, I BELIEVE THIS WAS JUST A BAD BATCH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture; Pain; Perforation of Vessels

  MAUDE report 20461541 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2. REPORTED ISSUE: WE ORDER OUR 22 GAUGE IVS THROUGH MED LINE AND NORMALLY DO NOT HAVE ISSUES. HOWEVER, THIS LAST ORDER OF THEM WE RECEIVED I BELIEVE 80% OR HIGHER OF THE BOX ARE DEFECTIVE. THE CATHETER PART OF THE IV IS WHAT IS SEEMING TO CAUSE MANY ISSUES WHEN STICKING PATIENTS AND ALSO CAUSING MULTIPLE STICKS TO BEFORE ONE IS SUCCESSFUL. IT IS ALMOST IMPOSSIBLE TO THREAD THE CATHETER THROUGH WITHOUT CAUSING DAMAGE AND DISCOMFORT TO THE VEIN. WE EVEN HAD THE CHAMBER OF ONE COME COMPLETELY OUT DURING INSERTION AND CAUSE BLEEDING FROM IT (WHEN THESE ARE SUPPOSED TO BE AUTO STOP). WE EVEN USED A DIFFERENT GAUGE FROM A LOCAL HOSPITAL AND EVERYTHING WORKED GREAT WITH IT (SAME BRAND). SO, I BELIEVE THIS WAS JUST A BAD BATCH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture; Pain; Perforation of Vessels

  MAUDE report 20461521 ↗
• MalfunctionAug 6, 2024Fail-Safe Problem; Fail-Safe Problem

  REPORTED ISSUE: PER CUSTOMER REPORT TO MEDLINE:" WE HAD AN EVENT WITH THIS ITEM (SEE BELOW). THE DEFECTIVE ITEM WASN'T SAVED, BUT WE WANTED TO BRING IT TO YOUR ATTENTION: WHEN ATTEMPTING TO PULL THE NEEDLE OUT, IT WAS STUCK INSIDE THE HUB. BY PULLING HARDER, THE RN WAS ABLE TO REMOVE THE NEEDLE, BUT THE SAFETY CAP MOVED TO THE MIDDLE OF THE NEEDLE, LEAVING THE NEEDLE EXPOSED CREATING A POTENTIAL SHARP EXPOSURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917602 ↗
• MalfunctionOct 17, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: IS3 VALVE NOT WORKING. DETAILED INQUIRY DESCRIPTION: UPON INSERTION OF 22G IS3 CATHETER, WHEN NEEDLE WAS RETRACTED, BLOOD POOLED OUT OF CATHETER. SEPTUM DID NOT ENGAGE TO STOP BLOOD AS IT WAS SUPPOSED TO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948645 ↗
• MalfunctionJan 4, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: "THE IV WAS STARTED AND HAD A FLASH INTO THE BASE OF THE IV SET. I WENT TO PULL THE NEEDLE OUT OF THE CATHETER AND IT WOULD NOT PULL OUT. I WAS PULLING STRAIGHT BACK. I PUT PRESSURE ONTO THE CATHETER WINGS AND PULLED THE NEEDLE STRAIGHT BACK AND IT STILL WOULD NOT RELEASE. I PUSHED DOWN ON THE CATHETER MORE AND USED MORE FORCE TO PULL THE NEEDLE BACK AND IT FINALLY RELEASED AFTER A COUPLE OF TRIES. WHEN THE NEEDLE CAME OUT OF THE CATHETER, THE NEEDLE GUARD WAS NOT ON THE END OF THE NEEDLE. IT WAS THREE QUARTERS OF THE WAY DOWN THE NEEDLE, TOWARD THE BASE. I BELIEVE THIS DEVICE WAS DEFECTIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093797 ↗
• MalfunctionNov 23, 2022Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: MRI CLINICIAN REPORTS THAT INTROCAN SAFETY 3 SAFETY SHIELD FELL OFF AS SHE REMOVED NEEDLE FROM CATHETER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854468 ↗
• MalfunctionSep 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: AFTER ATTEMPTING TO INJECT PROPOFOL, THEY NOTICE A PARTICLE IN THE FLUID PATH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501744 ↗
• MalfunctionSep 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: AFTER ATTEMPTING TO INJECT PROPOFOL, THEY NOTICE A PARTICLE IN THE FLUID PATH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501664 ↗
• MalfunctionSep 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: AFTER ATTEMPTING TO INJECT PROPOFOL, THEY NOTICE A PARTICLE IN THE FLUID PATH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501388 ↗
• MalfunctionNov 20, 2020Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY USER FACILITY: THE REPORT FROM THE ED TRAUMA BAY WAS THAT THE SAFETY MECHANISM, AFTER DEPLOYED, WAS NOT CONSISTENTLY STAYING OVER THE NEEDLE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874657 ↗
• MalfunctionJan 27, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: SAFETY SHIELD DISENGAGED AND A NEEDLESTICK OCCURRED. THE MEDIC PUT THE USED CATHETER TO THE SIDE, AND WHEN HE WENT TO DISPOSE OF THE STYLETTE HE GOT STUCK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9634501 ↗
• MalfunctionFeb 20, 2019Break; Break

  AS REPORTED BY USER FACILITY: BROKEN TIP. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353188 ↗
• MalfunctionJun 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: DURING THE INSERTION PROCESS, THE FLASH PLUG FELL OFF AND BLOOD WAS COMING OUT. NO PATIENT INJURY.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7605756 ↗