INTROCAN SAFETY® 4252500-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04046963165963), received between Jan 30, 2017 and Mar 19, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

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.

• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED FROM MEDSUN UF/ IMPORTER REPORT # (B)(4): DESCRIBE THE EVENT OR PROBLEM: WHILE PLACING IV, CATHETER WAS NOT KINKED WHEN THEY INSERTED IT, HOWEVER WHEN THEY WENT TO FLUSH IT, SALINE/ BLOOD SPRAYED BACK FROM THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641339 ↗
• MalfunctionApr 10, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION. SMALL BREAK IN IV CATHETER. DETAILED INQUIRY DESCRIPTION NURSE STATES "STARTING AN IV IN THE HAND. THE ATTEMPT WAS UNSUCCESSFUL SO I PULLED THE IV NEEDLE OUT BUT WHEN I WENT TO REMOVE THE IV CATHETER I WAS MET WITH RESISTANCE. WHEN I PULLED THE CATHETER OUT THERE WAS SMALL BREAK IN THE CATHETER. THE CATHETER WAS INTACT." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079495 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  PER MEDWATCH (B)(4): EVENT 2: EVENT OCCURRED IN OUTPATIENT TREATMENT FACILITY. REPORT STATES "TWO CATHETERS WOULD NOT THREAD INTO VEIN OF THE PATIENT. BLOOD LEAKING FROM HOLE INSIDE OF CATHETER. WHEN CATHETERS WERE REMOVED, THERE WERE VISIBLE HOLES IN BOTH CATHETERS THAT COULD BE SEEN WHEN FLUSHING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331284 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  PER MEDWATCH (B)(4). EVENT 1: EVENT OCCURRED IN OUTPATIENT TREATMENT FACILITY. REPORT STATES "TWO CATHETERS WOULD NOT THREAD INTO VEIN OF THE PATIENT. BLOOD LEAKING FROM HOLE INSIDE OF CATHETER. WHEN CATHETERS WERE REMOVED, THERE WERE VISIBLE HOLES IN BOTH CATHETERS THAT COULD BE SEEN WHEN FLUSHING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331283 ↗
• MalfunctionSep 14, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: "DURING AN IV ATTEMPT IN A PATIENT ROOM, THE PIV BRAUN WAS PLACED. WHEN FLUSHING THE IV, THE SALINE BEGAN LEAKING AROUND THE HUB OF THE IV. WHEN FLUSHING STOPPED, BLOOD BEGAN LEAKING AROUND THE PIV HUB. PIV ATTEMPT WAS UNSUCCESSFUL DUE TO PIV LEAKING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743693 ↗
• MalfunctionNov 16, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: "ONE OF OUR MEDICS PLACED AN IV ON A PATIENT THIS MORNING WHILE I WAS IN THE ROOM, SHE HAD NO PROBLEM PLACING IT. THE IV SITE WAS IN THE ANTECUBITAL AND THE PATIENT'S ARM WAS COMPLETELY STRAIGHT. THE PATIENT WAS NOT MOVING. THE MEDIC DID NOT MEET ANY RESISTANCE WHEN PLACING THE IV. WHEN SHE WENT TO FLUSH THE LINE WITH NORMAL SALINE (ABOUT 3 MLS) SHE NOTICED A LOT OF SALINE AND BLOOD COMING OUT AROUND THE INSERTION SITE. SHE CALLED ME OVER TO LOOK AT IT. I ASKED HER IF IT WAS THE INSERTION SITE OR THE CATHETER LEAKING. SHE PULLED THE CATHETER BACK A BIT SO THE HUB (YELLOW PART OF IV) WASN'T DIRECTLY UP AGAINST THE SKIN AND FLUSHED AGAIN. THIS TIME WE BOTH COULD CLEARLY SEE IT WAS COMING OUT BETWEEN THE HUB AND CATHETER. I TOLD HER TO PULL THE IV OUT AND PLACE A NEW ONE. WHEN SHE DID THAT ONLY THE HUB ( YELLOW PART) WAS IN HER HAND. THE ACTUAL CATHETER PORTION WAS STILL IN THE PATIENT'S VEIN. IT WAS OUT FAR ENOUGH THAT SHE WAS ABLE TO PULL THE CATHETER OUT WITH HER FINGERS."

  Patient problems: Needle Stick/Puncture

  MAUDE report 15804596 ↗
• MalfunctionMay 25, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION RN WAS INSERTING PIV. WHEN ADVANCING CATHETER, RN NOTICED HOLE IN CATHETER (PATIENT'S BLOOD WAS LEAKING OUT OF THE SIDE OF THE CATHETER). CATHETER REMOVED INTACT AND DISCARDED. PIV INITIATED WITH NEW CATHETER. NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14495350 ↗
• 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 13599950 ↗
• MalfunctionJun 7, 2021Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED THROUGH MEDWATCH (B)(4): UPON PLACING A PIV, THE SAFETY DEVICE ON THE NEEDLE MALFUNCTIONED AND DID NOT ENGAGE. HIGH POTENTIAL FOR NEEDLE STICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11948448 ↗
• MalfunctionMar 11, 2020Break; Break

  AS REPORTED BY USER FACILITY: EVENT 3: PART OF THE SHEATH REMAINED IN BABY WHEN THE CATHETER WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9819879 ↗
• MalfunctionMar 11, 2020Break; Break

  AS REPORTED BY USER FACILITY: EVENT 2: PART OF THE SHEATH REMAINED IN BABY WHEN THE CATHETER WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9819873 ↗
• MalfunctionMar 11, 2020Break; Break

  AS REPORTED BY USER FACILITY: EVENT 1: PART OF THE SHEATH REMAINED IN BABY WHEN THE CATHETER WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9819871 ↗
• MalfunctionMar 27, 2019Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak; Protective Measures Problem

  AS REPORTED BY USER FACILITY: INTROCAN SAFETY SHIELD NOT ENGAGING WHEN PULLING OUT AND LEAK AT CONNECTION TO EXT. SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8457980 ↗
• MalfunctionFeb 27, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: A NURSE WAS STARTING AN IV ON A PATIENT WHEN THE IV INFILTRATED. WHEN SHE REMOVED THE CATHETER, THE SAFETY MECHANISM DID NOT ENGAGE AND THE NURSE HAD A NEEDLE STICK IN HER INDEX FINGER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8374240 ↗
• MalfunctionJan 30, 2017Positioning Problem; Positioning Problem

  AS REPORTED BY THE USER FACILITY: EVENT 5: CUSTOMER REPORTS, "HAS HAD PATIENTS OVER THE LAST 2 MONTHS WHO HAVE HAD PHLEBITIS AT INSERTION SITE. ALL HAVE DIAGNOSIS OF CHRONIC REGIONAL PAIN SYNDROME. ALL COMPLAINED OF BURNING WHEN DRUG ADMINISTERED, PHLEBITIS NOTED AT SITE ANYWHERE FROM 5 HOURS TO 3 DAYS OF DWELL TIME. PHLEBITIS SYMPTOMS ANYTHING FROM SMALL RED SWOLLEN AT INSERTION SITE TO RED STREAK UP VEIN. REPORTS ALL WERE TREATED WITH AND RESPONDED WELL TO AMOXICILLIN, NO OTHER INTERVENTION REQUIRED. ALL ARE ATTENDING KETAMINE CLINIC FOR PAIN, ALL RECEIVING DRUG, ALL HAVE SAME SITE PREP AND DRESSING. ALL IV'S STARTED BY SAME NURSE. REPORTS MOST OF THESE PATIENTS DID NOT HAVE HISTORIES OF SKIN REACTIONS TO DIFFERENT PRODUCTS OR MANY ALLERGIES. CUSTOMER REPORTS 10 EVENTS; HOWEVER, IT IS UNKNOWN IF THE UNITS WERE MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392 OR MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318, SO THE COMPLAINT UNITS WERE SPLIT EVENLY BETWEEN TWO PIRS: 400330840: MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392: 5 COMPLAINT UNITS; 400330974: MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318: 5 COMPLAINT UNITS.

  Patient problems: Vasculitis

  MAUDE report 6287642 ↗
• MalfunctionJan 30, 2017Positioning Problem; Positioning Problem

  AS REPORTED BY THE USER FACILITY: EVENT 4: CUSTOMER REPORTS, "HAS HAD PATIENTS OVER THE LAST 2 MONTHS WHO HAVE HAD PHLEBITIS AT INSERTION SITE. ALL HAVE DIAGNOSIS OF CHRONIC REGIONAL PAIN SYNDROME. ALL COMPLAINED OF BURNING WHEN DRUG ADMINISTERED, PHLEBITIS NOTED AT SITE ANYWHERE FROM 5 HOURS TO 3 DAYS OF DWELL TIME. PHLEBITIS SYMPTOMS ANYTHING FROM SMALL RED SWOLLEN AT INSERTION SITE TO RED STREAK UP VEIN. REPORTS ALL WERE TREATED WITH AND RESPONDED WELL TO AMOXICILLIN, NO OTHER INTERVENTION REQUIRED. ALL ARE ATTENDING KETAMINE CLINIC FOR PAIN, ALL RECEIVING DRUG, ALL HAVE SAME SITE PREP AND DRESSING. ALL IV'S STARTED BY SAME NURSE. REPORTS MOST OF THESE PATIENTS DID NOT HAVE HISTORIES OF SKIN REACTIONS TO DIFFERENT PRODUCTS OR MANY ALLERGIES. CUSTOMER REPORTS 10 EVENTS; HOWEVER, IT IS UNKNOWN IF THE UNITS WERE MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392 OR MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318, SO THE COMPLAINT UNITS WERE SPLIT EVENLY BETWEEN TWO PIRS: (B)(4): MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392: 5 COMPLAINT UNITS; (B)(4): MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318: 5 COMPLAINT UNITS.

  Patient problems: Vasculitis

  MAUDE report 6287640 ↗
• MalfunctionJan 30, 2017Positioning Problem; Positioning Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS, "HAS HAD PATIENTS OVER THE LAST 2 MONTHS WHO HAVE HAD PHLEBITIS AT INSERTION SITE. ALL HAVE DIAGNOSIS OF CHRONIC REGIONAL PAIN SYNDROME. ALL COMPLAINED OF BURNING WHEN DRUG ADMINISTERED, PHLEBITIS NOTED AT SITE ANYWHERE FROM 5 HOURS TO 3 DAYS OF DWELL TIME. PHLEBITIS SYMPTOMS ANYTHING FROM SMALL RED SWOLLEN AT INSERTION SITE TO RED STREAK UP VEIN. REPORTS ALL WERE TREATED WITH AND RESPONDED WELL TO AMOXICILLIN, NO OTHER INTERVENTION REQUIRED. ALL ARE ATTENDING KETAMINE CLINIC FOR PAIN, ALL RECEIVING DRUG, ALL HAVE SAME SITE PREP AND DRESSING. ALL IV'S STARTED BY SAME NURSE. REPORTS MOST OF THESE PATIENTS DID NOT HAVE HISTORIES OF SKIN REACTIONS TO DIFFERENT PRODUCTS OR MANY ALLERGIES. CUSTOMER REPORTS 10 EVENTS; HOWEVER, IT IS UNKNOWN IF THE UNITS WERE MATERIAL NUMBER (B)(4)/BATCH NUMBER 16C16G8392 OR MATERIAL NUMBER (B)(4)/BATCH NUMBER 16F01G8318, SO THE COMPLAINT UNITS WERE SPLIT EVENLY BETWEEN TWO PIRS: (B)(4): MATERIAL NUMBER (B)(4)/BATCH NUMBER 16C16G8392: 5 COMPLAINT UNITS, (B)(4): MATERIAL NUMBER (B)(4)/BATCH NUMBER 16F01G8318: 5 COMPLAINT UNITS.

  Patient problems: Vasculitis

  MAUDE report 6287631 ↗
• MalfunctionJan 30, 2017Positioning Problem; Positioning Problem

  AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS, "HAS HAD PATIENTS OVER THE LAST 2 MONTHS WHO HAVE HAD PHLEBITIS AT INSERTION SITE. ALL HAVE DIAGNOSIS OF CHRONIC REGIONAL PAIN SYNDROME. ALL COMPLAINED OF BURNING WHEN DRUG ADMINISTERED, PHLEBITIS NOTED AT SITE ANYWHERE FROM 5 HOURS TO 3 DAYS OF DWELL TIME. PHLEBITIS SYMPTOMS ANYTHING FROM SMALL RED SWOLLEN AT INSERTION SITE TO RED STREAK UP VEIN. REPORTS ALL WERE TREATED WITH AND RESPONDED WELL TO AMOXICILLIN, NO OTHER INTERVENTION REQUIRED. ALL ARE ATTENDING KETAMINE CLINIC FOR PAIN, ALL RECEIVING DRUG, ALL HAVE SAME SITE PREP AND DRESSING. ALL IV'S STARTED BY SAME NURSE. REPORTS MOST OF THESE PATIENTS DID NOT HAVE HISTORIES OF SKIN REACTIONS TO DIFFERENT PRODUCTS OR MANY ALLERGIES. CUSTOMER REPORTS 10 EVENTS; HOWEVER, IT IS UNKNOWN IF THE UNITS WERE MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392 OR MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318, SO THE COMPLAINT UNITS WERE SPLIT EVENLY BETWEEN TWO PIRS: (B)(4): MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392: 5 COMPLAINT UNITS; (B)(4): MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318: 5 COMPLAINT UNITS.

  Patient problems: Vasculitis

  MAUDE report 6287628 ↗
• MalfunctionJan 30, 2017Positioning Problem; Positioning Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS, "HAS HAD PATIENTS OVER THE LAST 2 MONTHS WHO HAVE HAD PHLEBITIS AT INSERTION SITE. ALL HAVE DIAGNOSIS OF CHRONIC REGIONAL PAIN SYNDROME. ALL COMPLAINED OF BURNING WHEN DRUG ADMINISTERED, PHLEBITIS NOTED AT SITE ANYWHERE FROM 5 HOURS TO 3 DAYS OF DWELL TIME. PHLEBITIS SYMPTOMS ANYTHING FROM SMALL RED SWOLLEN AT INSERTION SITE TO RED STREAK UP VEIN. REPORTS ALL WERE TREATED WITH AND RESPONDED WELL TO AMOXICILLIN, NO OTHER INTERVENTION REQUIRED. ALL ARE ATTENDING KETAMINE CLINIC FOR PAIN, ALL RECEIVING DRUG, ALL HAVE SAME SITE PREP AND DRESSING. ALL IV'S STARTED BY SAME NURSE. REPORTS MOST OF THESE PATIENTS DID NOT HAVE HISTORIES OF SKIN REACTIONS TO DIFFERENT PRODUCTS OR MANY ALLERGIES. CUSTOMER REPORTS 10 EVENTS; HOWEVER, IT IS UNKNOWN IF THE UNITS WERE MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392 OR MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318, SO THE COMPLAINT UNITS WERE SPLIT EVENLY BETWEEN TWO PIRS: 400330840: MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392: 5 COMPLAINT UNITS; 400330974: MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318: 5 COMPLAINT UNITS.

  Patient problems: Vasculitis

  MAUDE report 6287626 ↗