INTROCAN SAFETY® 4251628-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964399091), received between Jun 22, 2018 and Jul 8, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN. "PRODUCT LEAKAGE." "THE USER NOTICED A LEAKAGE FROM THE CONNECTION WHEN THE USER PIERCED THE PATIENT, CONNECTED AN EXTENSION TUBE, FLUSHED IT WITH PHYSIOLOGICAL SALINE TO CHECK FOR REVERSE BLOOD. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958208 ↗
• MalfunctionJun 10, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4): " AIR IN THE SYRINGE." "THE PATIENT WAS ON NORADRENALINE INFUSION RUNNING AT APPROX. 10MLS/HR, THE INTENDED FLUID VOLUME WAS APPROX. 30MLS. THE PATIENTS BP WAS DROPPING SO WE WENT UP ON THE INFUSION RATE TO 15MLS/HR THEN TO 20MLS/HR BUT THE PATIENT'S BP REMAINED UNCHANGED. THE NURSE CHECKED THE PATIENTS CVC TO MAKE SURE THERE WAS NO KINK IN THE LINE- THERE WASN'T. SHE CHECKED THE PUMP, OPENED THE DOOR AND COULD SEE APPROX. 20MLS OF AIR IN THE SYRINGE SO THE SYRINGE LOOKED HALF FILLED WHEN LYING FLAT. THE PATIENTS BP RECOVERED WHEN THE NORAD INFUSION WAS CHANGED QUICKLY TO THE 2ND NORAD INFUSION THAT WAS ON STANDBY."

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 14653151 ↗
• MalfunctionJun 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4). "PRODUCT LEAKAGE." AFTER PUNCTURING THE PATIENT, AN EXTENSION TUBE WAS CONNECTED TO IT AND FLUSHED WITH PHYSIOLOGICAL SALINE. AT THAT TIME, WHEN THE USER CONFIRMED THE REVERSE BLOOD, HE NOTICED A LEAK FROM THE CONNECTION PART. THE SAME EVENT ALSO HAPPENED A MONTH AGO. THERE ARE NO USED ACTUAL PRODUCTS AND WE WILL SEND 24 OF THE SAME LOT PRODUCTS, SO PLEASE INVESTIGATE. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIENT: NONE / SAMPLE: AVAILABLE, WILL BE SHIPPED LATER. / BATCH: 21N08G8371."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578296 ↗
• MalfunctionJun 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6). "PRODUCT LEAKAGE." "DURING PRIMING OF INFUSION PREPARATION IN THE CHEMOTHERAPEUTIC ROOM, A LIQUID LEAK OCCURRED FROM THE JMS INFUSION SET CONNECTION. THIS IS THE SECOND CASE AT THIS DEPARTMENT, AND LOT IS DIFFERENT FROM THE LAST TIME. ABOUT 5 SAME CASES HAVE OCCURRED AT THIS FACILITY. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIENT: NONE / SAMPLE: AVAILABLE, WILL BE SHIPPED LATER. / BATCH: 21H29G8371."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578112 ↗
• MalfunctionJun 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6). "PRODUCT LEAKAGE." "AFTER INSERTING THE PRODUCT TO THE PATIENT, WHEN IT WAS CONNECTED TO THE EXTENSION TUBE AND TRIED THE MEDICAL LIQUID TO FLOW, THE LEAKAGE FROM THE CONNECTION PART WAS CONFIRMED. IN ADDITION, SYRINGE WAS CONNECTED TO THE PRODUCT AND TRIED TO BE PULLED, ONLY AIR WAS PULLED. NO INFECTION TO THE PATIENT/ NO HEALTH HAZARD TO THE PATIENT/SAMPLE AVAILABLE/ BATCH 21L07G8374".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578056 ↗
• MalfunctionJun 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6). "PRODUCT LEAKAGE." " AFTER CONNECTING THE TOP EXTENSION TUBE AND PERFORMED HEPA FLUSHING, A LIQUID LEAK WAS FOUND FROM THE CONNECTION PART. (SYRINGE + EXTENSION TUBE WILL BE SENT TOGETHER) . WE WILL ALSO SEND UNUSED ITEMS OF THE SAME LOT. CONNECTION PARTNER : TOP EXTENSION TUBE / NO SAMPLE. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIENT: NONE / SAMPLE: AVAILABLE, WILL BE SHIPPED LATER. BATCH: 21L07G8374."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578046 ↗
• MalfunctionJun 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6) "PRODUCT LEAKAGE." "THE USER CONNECTED TO AN EXTENSION TUBE TO FLUSH THE CONTRAST AGENT AND STARTED ADMINISTRATION. AFTER THAT, IT LEAKED FROM THE CONNECTION PART WITH WRINKLES. IT WAS CONNECTED TO TOP'S X1.5-FL150CT. THE USER CONNECTED IT TO THE SYRINGE AND CHECKED IT, BUT ALSO CONFIRMED THE LEAK. WE WILL ALSO COLLECT AND SEND ALL UNUSED ITEMS OF THE SAME LOT AS THE TWO ACTUAL ITEMS. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIENT: NONE / SAMPLE: AVAILABLE / BATCH : 21L07G8374."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577953 ↗
• MalfunctionSep 27, 2018Break; Break

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN COLOMBIA: PART OF THE MEDICAL DEVICE INTO PATIENT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7916716 ↗
• MalfunctionSep 27, 2018Break; Break

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN CHINA: BROKEN PIPE OF INDWELLING NEEDLE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7916715 ↗
• MalfunctionJun 29, 2018Device Issue; Device Issue

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN: SAFETY CLIP CAME OFF

  Patient problems: Needle Stick/Puncture

  MAUDE report 7649593 ↗
• MalfunctionJun 22, 2018Device Operational Issue; Device Operational Issue

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN: NEEDLESTICK INJURY (SAFETY CLIP FAILURE)

  Patient problems: Needle Stick/Puncture

  MAUDE report 7629321 ↗