INTROCAN SAFETY® 4251628-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04046963166021), received between Mar 1, 2017 and Mar 30, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: PERIPHERAL IV PLACED AND SAFETY MECHANISM TO SHIELD NEEDLE DID NOT RETRACT UPON NEEDLE WITHDRAWAL, EXPOSING THE NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715266 ↗
• InjuryNov 4, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE EVENT DESCRIPTION: IN A HOSPITAL, NURSING STAFF USED AN EASY PUMP LT270-27 DIFFUSER, BBRAUN REFERENCE (B)(4), BATCH 24D20GED41 ON A PATIENT. THE DIFFUSER WAS FILLED WITH 5 FLUOROURACYL FOR A QUANTITY OF 1750MG (MILLIGRAMS) (35 ML (MILLILITERS)), DILUTED IN NACL 0.9% (VOL 192ML). THE INFUSION WAS INITIATED ON (B)(6) 2024 AT 5PM. ON (B)(6) 2024 AT 8:30AM, THE NURSING STAFF NOTICED THAT THE DIFFUSER WAS EMPTY. THE INFUSION THEREFORE LASTED 15 HOURS 30 MINUTES INSTEAD OF THE EXPECTED 22 HOURS. THE DIFFUSER INFUSED MUCH FASTER THAN EXPECTED. THE PATIENT WAS MORE PRONE TO NAUSEA THAN DURING THE PREVIOUS TREATMENT. THE DIFFUSER IS IN QUARANTINE AT THE CUSTOMER'S FACILITY. WE ARE DUE TO COLLECT IT ON WEDNESDAY (B)(6) 2024.

  Patient problems: Discomfort

  MAUDE report 20604059 ↗
• InjuryOct 31, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE EVENT DESCRIPTION: THE NURSE REPORT CATHETER FRAGMENTATION AFTER INSPECTION WITH CATHETER REMOVAL DUE TO EXTRAVASATION. TOTAL CATHETER FRAGMENT MIGRATION THROUGH VEINS IS CURRENTLY UNDER EVALUATION. WRITTEN REPORT DOES NOT DESCRIBE SURGICAL REMOVAL OR PERCUTANEOUS EXTRACTION. VERBAL REPORTS INDICATE FAILED SURGICAL REMOVAL ATTEMPT. OFFICIAL REPORT FROM CUSTOMER AND SALES REP VERBAL REPORT ATTACHED.

  Patient problems: Extravasation; Foreign Body In Patient

  MAUDE report 20576634 ↗
• MalfunctionAug 13, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: "RN PLACED #22-GAUGE INTROCAN IV IN PATIENT'S RIGHT AC. IV STARTED" [PLEASE NOTE THAT THIS WAS A WEB SUBMISSION AND THE COMPLAINT DESCRIPTION WAS CUT OFF] "1. THE COMPLAINT DESCRIPTION MENTIONS A PICTURE, BUT NO PICTURE WAS PROVIDED. CAN THE PICTURE OF THE ISSUE BE PROVIDED? 2. CAN YOU PLEASE PROVIDE ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INCIDENT? PREOP RN WAS ATTEMPTING TO START IV. UNSUCCESSFUL IV START. WHEN PREOP RN REMOVED IV WITH NEEDLE, PREOP RN NOTICED THAT THE CATHETER WAS BENT/BROKEN. PREOP RN KEPT SUPPLY AND MATERIALS MANAGEMENT MADE AWARE. 3 WAS THERE ANY PATIENT INVOLVEMENT OR HARM? IF SO, WERE ANY MEDICAL INTERVENTIONS NECESSARY? PATIENT HAD TO BE STUCK AGAIN FOR AN IV. NO OTHER HARM WAS NOTED."

  Patient problems: Needle Stick/Puncture

  MAUDE report 19971318 ↗
• MalfunctionDec 19, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED PER MEDWATCH FORM MW5148304: "HILE INSERTING AN IV (INTRAVENOUS CATHETER) INTO A PATIENT IN THE OR (OPERATING ROOM) AND AFTER I ADVANCED THE CATHETER INTO THE VEIN AND TRIED TO REMOVE THE NEEDLE, THE NEEDLE MET SOME RESISTANCE COMING OUT AND THE SAFETY TIP ACTUALLY SNAPPED OFF THE NEEDLE AND REMAINED IN THE CATHETER. THE NEEDLE PORTION WAS REMOVED, BUT THE SAFETY TIP SNAPPED OFF THE END OF THE NEEDLE AND REMAINED IN THE CATHETER. WE LET SOME BLOOD FLOW THROUGH THE CATHETER, AND IT PUSHED THE SAFETY TIP OUT AND WE WERE ABLE TO GRAB IT WITH A SURGICAL INSTRUMENT. THE SAFETY TIP THAT WAS REMOVED WAS INTACT AND THERE WAS NOTHING LEFT BEHIND IN THE CATHETER OR IN THE PATIENT." BRAND NAME: 22GAUGEX1 IN SAFETY IV CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355017 ↗
• MalfunctionOct 13, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: NEEDLESTICK INJURY WITH INTROCAN SAFETY. DETAILED INQUIRY DESCRIPTION: CUSTOMER HAS REPORTED THAT SAFETY MECHANISM ON INTROCAN SAFETY DID NOT ENGAGE WHICH HAS RESULTED IN A NEEDLESTICK INJURY OF THE USER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17929647 ↗
• MalfunctionJun 7, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CATHETER WAS BROKEN. THE TIP OF THE NEEDLE WAS INTACT. THIS WAS IN-USE WITHIN THE PATIENT'S VEIN WITH A MALFUNCTION WAS SUSPECTED AND THE IV IMMEDIATELY REMOVED FROM PATIENT. NO FOREIGN BODY RETAINED. DRESSING APPLIED. SITE LOOKED APPROPRIATE FOR POST-IV REMOVAL AT DC. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14618581 ↗
• MalfunctionFeb 1, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: THE SAFETY ON THIS NEEDLE DID NOT ACTIVATE AND THIS RESULTED IN A NEEDLE STICK AND EXPOSURE TO ONE OF THE NURSES. WHILE HOLDING PRESSURE ON THE SITE, I ATTEMPTED TO MOVE THE NEEDLE AWAY FROM THE PATIENT AND DID NOT NOTICE THAT THE NEEDLE TIP WAS NOT COVERED BY THE SAFETY SHIELD. I GRABBED THE NEEDLE AT THE HUB WITH MY THUMB AND INDEX FINGER BUT WAS STUCK IN MY RING FINGER OF THE SAME HAND.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11260008 ↗
• MalfunctionNov 20, 2020Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY USER FACILITY: A NURSE IN PREOP HAD STARTED AN IV AND AFTER COMPLETION OF THE PROCESS SHE WAS GATHERING HER USED SUPPLIES FOR THE TRASH AND DID NOT SEE THE NEEDLE. SHE WAS STUCK WITH THE NEEDLE, THRU HER GLOVE AND IT DID DRAW BLOOD FROM HER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10874658 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 9. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428614 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 7. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428613 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 8. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428610 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 1: CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428609 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 5. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428608 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 2. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428607 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 3. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428606 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 4. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428604 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 6. CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428603 ↗
• MalfunctionMar 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: EVENT 10: CATHETERS HAVE A VISIBLE PLASTIC COVERING THE NEEDLE WHEN REMOVED FROM THE PROTECTIVE COVER, ALL WERE VISIBLE ENOUGH TO DISCARD THE PRODUCT PRIOR TO USE. THERE IS NO WAY TO REMOVE WITHOUT CONTAMINATING THE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428599 ↗
• MalfunctionSep 29, 2017Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY THE USER FACILITY: THE SAFETY SHIELD DID NOT ACTIVATE WHEN THE NEEDLE WAS REMOVED FROM THE CATHETER. NO PATIENT OR CLINICIAN INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6905293 ↗
• MalfunctionSep 13, 2017Break; Break

  AS REPORTED BY USER FACILITY: A 4 MM PORTION OF AN INTROCAN CATHETER BROKE DURING THE CATHETER REMOVAL PROCEDURE. HOWEVER, THE DOPPLER EXAM PERFORMED SHOWED THAT THERE WAS NO CATHETER BROKEN & LEFT INSIDE THE BLOOD VESSEL OF THIS PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861215 ↗
• InjuryMar 1, 2017Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN): SAFETY CLIP DID NOT WORK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6368483 ↗
• MalfunctionMar 1, 2017Component Missing; Component Missing

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN): THE CLIP WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6368478 ↗