INTROCAN SAFETY® 4251601-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046963166274), received between Jan 30, 2017 and Dec 11, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE EVENT DESCRIPTION: A PERIPHERAL PUNCTURE IS PERFORMED WITH A 24 CATHETER ON A PATIENT WHO DOES NOT OBSERVE A RETURN THROUGH THE CHAMBER BUT THROUGH THE WALLS OF THE SAME. IT IS VERIFIED AND A DYSFUNCTIONAL CATHETER IS REMOVED AND IT IS VERIFIED WHERE IT IS OBSERVED TO BE BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907445 ↗
• MalfunctionAug 7, 2024Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: PER CUST "WE HAD A PIV NEEDLE ISSUE WHERE THE NEEDLE WENT THROUGH THE SAFETY MECHANISM EXPOSING THE SHARPS END. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927751 ↗
• MalfunctionJun 28, 2024Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION THE PASSIVE SAFETY CLIP DID NOT ENGAGE WHEN THE NEEDLE WAS REMOVED FROM THE CATHETER. DETAILED INQUIRY DESCRIPTION THE NURSE INSERTED THE IV SUCCESSFULLY AND WHEN THE NEEDLE WAS REMOVED, THE PASSIVE SAFETY CLIP DID NOT ENGAGE AND THE NURSE WAS STUCK WHEN PUTTING THE NEEDLE DOWN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19639069 ↗
• MalfunctionNov 13, 2020Leak/Splash; Leak/Splash

  AS REPORTED BY USER FACILITY: BLOOD LEAKED AROUND THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10835943 ↗
• MalfunctionDec 18, 2018Break; Break

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN COLOMBIA): PART OF THE CATHETER REMAINED IN THE ARM

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8173828 ↗
• 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 (B)(6) 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: FIVE COMPLAINT UNITS. (B)(4): MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318: FIV. COMPLAINT UNITS

  Patient problems: Vasculitis

  MAUDE report 6287717 ↗
• 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 (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 6287656 ↗
• 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: 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 6287653 ↗
• 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 6287650 ↗
• 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 6287636 ↗