INTROCAN SAFETY® 4252519-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04046963165949), received between May 30, 2017 and Jun 17, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Break

  AS REPORTED ON MW (B)(4): 22G IV CATHETER BROKE UPON ATTEMPTED IV REMOVAL. THE CLEAR CATHETER PORTION BROKE APART FROM THE BLUE HUB. THE PATIENT WAS TAKEN TO THE IR LAB FOR RETAINED FOREIGN BODY RETRIEVAL. THE FOREIGN BODY WAS REMOVED COMPLETELY. BEDSIDE RN REMOVED DRESSING ON RT FOREARM PIV TO ASSESS LEAKING, NOTED THAT HUB BROKE OFF FROM CATHETER, AND CATHETER APPEARS TO BE RETAINED IN THE BODY. RN CALLED VAD TO ASSESS. VAD ASKED RN TO APPLY TOURNIQUET TO RT UPPER ARM, IMMEDIATELY CAME TO BEDSIDE. PT IS CALM, NO DISTRESS. VAD CAN SEE CATHETER FRAGMENT ON US RETAINED IN LOWER RT FOREARM CEPHALIC VEIN; I MARKED LOCATION WITH STERILE SKIN PEN. THIS VAD RN REMAINED AT BEDSIDE, CONTINUOUSLY MONITORING PT, KEPT TOURNIQUET ON RT UPPER ARM, APPLIED HAND TOURNIQUET TO UPPER FOREARM, PERIODICALLY CHECKED THAT CATHETER PIECE REMAINED IN SAME PLACE ON US, ENSURED THAT PT KEPT RT ARM STILL/RELAXED AND DID NOT GET OUT OF BED, HAD PT CALL HER MOM SO I COULD UPDATE HER AND ASK HER TO COME BACK TO THE HOSPITAL. COVERING MDS (INTERN, FELLOW, ATTENDING) CAME TO BEDSIDE TO ASSESS AND UPDATE, STATE IR TEAM WILL COME IN EMERGENTLY TO REMOVE CATHETER FRAGMENT. THIS VAD RN REMAINED AT BEDSIDE CONTINUOUS

  Patient problems: Foreign Body In Patient

  MAUDE report 25536938 ↗
• MalfunctionMar 24, 2026Break; Difficult to Advance; Material Deformation

  THE COMPLAINANT REPORTED THAT A 22 GAUGE PERIPHERAL INTRAVENOUS LINE (PIV) CATHETER WAS PLACED WITH CONFIRMED BLOOD RETURN. BLOOD WAS SUCCESSFULLY OBTAINED FOR LABORATORY TESTING AT THE TIME OF PLACEMENT. UPON FLUSHING THE CATHETER FOLLOWING BLOOD COLLECTION, RESISTANCE WAS ENCOUNTERED; HOWEVER, BLOOD RETURN REMAINED VISIBLE. THE TRANSPARENT DRESSING WAS REMOVED TO BETTER ASSESS THE INSERTION SITE. THE PIV SITE WAS NOTED TO BE TENDER, AND THE VEIN APPEARED COMPROMISED ("BLOWN"). THE CATHETER WAS REMOVED. UPON INSPECTION, THE CATHETER TIP APPEARED FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681115 ↗
• MalfunctionJul 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION BUMPS/PROTRUSIONS ON INTROCAN CATHETER CANNULA DETAILED INQUIRY DESCRIPTION RECEIVED NOTICE FROM A CUSTOMER OF OMS THAT THEY HAVE SEEN MULTIPLE INTROCAN 22GAUGE CATHETERS WITH WHITE BUMPS/PROTRUSIONS ON THE CANNULA MAKING IT IMPOSSIBLE TO INSERT INTO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667370 ↗
• InjuryMar 14, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED DURING A LIVE CALL THE INTROCAN SAFETY FEP 22G, 0.9X25MM-US BROKE OFF IN A PATIENT VEIN DURING INSERTION. NURSE ATTEMPTED TO INSERT THE DEVICE - BLOOD WAS RETURNED SO SHE REMOVED THE NEEDLE. WHEN THE NURSE TRIED THE FLUSH THE DEVICE, SHE WAS NOTED IT WAS NOT IN AND THEN REMOVED THE DEVICE, AND ONLY HALF OF THE DEVICE CAME OUT - THE OTHER HALF WAS IN THE PATIENT VEIN. THIS MORNING THE PATIENT WAS GOING TO BE TAKEN DOWN FOR IMAGING TO DETERMINE FURTHER PATIENT CARE AND MEDICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21605915 ↗
• MalfunctionFeb 1, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: RN (WHO IS AN EXPERIENCED POWER USER OF INTROCAN) RETRACTED THE NEEDLE BACK AND THE SAFETY SHIELD DID NOT COMPLETELY COVER THE TIP, THE SAFETY SHIELD WAS SEATED ON THE MIDDLE OF THE NEEDLE EXPOSING THE TIP OF THE NEEDLE. THE NEEDLE WAS PLACED DOWN ON THE TABLE TO COMPLETE THE IV INSERTION ON THE PATIENT AND WHEN THE NURSE WENT TO DISCARD THE NEEDLE INTO THE SHARPS CONTAINER, SHE WAS STUCK ON THE RIGHT FOREFINGER BY THE EXPOSED NEEDLE TIP. NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16277596 ↗
• MalfunctionOct 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE NURSE NOTICED THAT THERE IS A DEBRIS OR A PLASTIC LIKE SPECK ON THE SIDE OF A BRAND NEW IV CATHETER WHEN HE OPENED THE PACKAGE AND TOOK THE CAP OFF THE NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15652898 ↗
• MalfunctionOct 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: THE NURSE NOTICED THAT THERE IS A DEBRIS OR A PLASTIC LIKE SPECK ON THE SIDE OF A BRAND NEW IV CATHETER WHEN HE OPENED THE PACKAGE AND TOOK THE CAP OFF THE NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15652866 ↗
• 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 13600006 ↗
• MalfunctionFeb 14, 2022Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: REPORTED THAT THE SAFETY CLIP DID NOT DEPLOY CORRECTLY WHEN NEEDLE WITHDRAWN FROM CATHETER. IT REMAINED CLOSER TO THE FLASH CHAMBER AND DID NOT COVER THE NEEDLE TIP. THERE WAS NO INJURY OR ANY ISSUE WITH THE IV THAT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524776 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: NOTICED SOME FUR ON THE TIP UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050548 ↗
• InjuryMar 9, 2021Break; Break

  AS REPORTED ON MW (B)(4): 22G IV CATHETER BROKE UPON ATTEMPTED IV REMOVAL. THE CLEAR CATHETER PORTION BROKE APART FROM THE BLUE HUB. THE PATIENT WAS TAKEN TO THE IR LAB FOR RETAINED FOREIGN BODY RETRIEVAL. THE FOREIGN BODY WAS REMOVED COMPLETELY. BEDSIDE RN REMOVED DRESSING ON RT FOREARM PIV TO ASSESS LEAKING, NOTED THAT HUB BROKE OFF FROM CATHETER, AND CATHETER APPEARS TO BE RETAINED IN THE BODY. RN CALLED VAD TO ASSESS. VAD ASKED RN TO APPLY TOURNIQUET TO RT UPPER ARM, IMMEDIATELY CAME TO BEDSIDE. PT IS CALM, NO DISTRESS. VAD CAN SEE CATHETER FRAGMENT ON US RETAINED IN LOWER RT FOREARM CEPHALIC VEIN, I MARKED LOCATION WITH STERILE SKIN PEN. THIS VAD RN REMAINED AT BEDSIDE, CONTINUOUSLY MONITORING PT, KEPT TOURNIQUET ON RT UPPER ARM, APPLIED HAND TOURNIQUET TO UPPER FOREARM, PERIODICALLY CHECKED THAT CATHETER PIECE REMAINED IN SAME PLACE ON US, ENSURED THAT PT KEPT RT ARM STILL/RELAXED AND DID NOT GET OUT OF BED, HAD PT CALL HER MOM SO I COULD UPDATE HER AND ASK HER TO COME BACK TO THE HOSPITAL. COVERING MDS (INTERN, FELLOW, ATTENDING) CAME TO BEDSIDE TO ASSESS AND UPDATE, STATE IR TEAM WILL COME IN EMERGENTLY TO REMOVE CATHETER FRAGMENT. THIS VAD RN REMAINED AT BEDSIDE CONTINUOUS

  Patient problems: Foreign Body In Patient

  MAUDE report 11446757 ↗
• MalfunctionOct 7, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: NOTED A PARTICULATE IN THE FLASHBACK CHAMBER, AFTER THE IV WAS STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10643473 ↗
• MalfunctionJul 20, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: WHEN STARTING AN IV CATHETER ON AN OUTPATIENT, THE SAFETY GUARD ON THE NEEDLE DID NOT ACTIVATE, LEAVING THE NEEDLE TIP EXPOSED. I NOTICED AS I WAS PULLING THE NEEDLE OUT AND THREADING THE CATHETER IN AND NO CONTACT WAS MADE WITH MY BODY OR PATIENT'S BODY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10298818 ↗
• MalfunctionJul 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: STARTED IV AND CONNECTED J LOOP TO IV CATHETER AND FLUIDS. A FEW MINUTES LATER NOTICED A POOL OF IV FLUIDS AND BLOOD ON THE SITE. SHE CHANGED THE J LOOP TO REMEDY, BUT THEN NOTICED A CRACK IN THE HUB OF THE IV CATHETER. NURSE THEN REMOVED THE IV CATHETER AND STARTED A NEW ONE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10298796 ↗
• MalfunctionDec 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: THE CATHETER WAS BEING USED IN AN ARTERIAL LINE, AND IT WAS BLEEDING. THE CATHETER WAS CRACKED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9503941 ↗
• MalfunctionMar 6, 2019Break; Break

  AS REPORTED BY USER FACILITY: 3 EVENTS WHERE THE IV CATHETER HAS SNAPPED INSIDE A PTS VEIN. WHEN ADDITIONAL INFORMATION WAS REQUESTED THE USER FACILITY INDICATED THAT THE CATHETERS DID NOT BREAK IN THE PATIENTS' VEINS, AND THAT THERE WAS NO INJURY TO THE PATIENTS AND NO INTERVENTION WAS REQUIRED IN ANY OF THE THREE EVENTS. AS NO SAMPLES ARE AVAILABLE FOR EVALUATION, B. BRAUN IS FILING THIS REPORT TO COVER THE POSSIBILITY THAT THE ORIGINAL REPORTED ISSUE MAY HAVE OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396219 ↗
• MalfunctionSep 12, 2018Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: NURSE WAS WITHDRAWING THE NEEDLE, AFTER INSERTION OF THE CATHETER AND NEEDLE. THE NEEDLE PENETRATED THE CATHETER JUST BELOW THE HUB, AND THE NURSE WAS STUCK BY THE NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7868258 ↗
• MalfunctionMay 30, 2017Break; Break

  AS REPORTED BY THE USER FACILITY: DURING PERIPHERAL INTRAVENOUS PLACEMENT, CATHETER BROKE OFF IN PATIENT. SURGICAL INTERVENTION REQUIRED TO EXTRACT THE CATHETER FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6598914 ↗