INTROCAN SAFETY® 4252527-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046963318185), received between Apr 20, 2018 and Jun 19, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Break

  AS REPORTED IN THE MEDSUN (B)(4). DESCRIBE THE EVENT OR PROBLEM: PT CONSENTED FOR A CAUDAL BLOCK PRIOR TO CHORDEE CORRECTION AND CIRCUMCISION WITH DR. 1 [REDACTED]. AFTER THE BLOCK TIMEOUT AND PREPPING, DR. 2 [REDACTED] STARTED THE CAUDAL BLOCK WITH DR. 3 [REDACTED] BY HER SIDE. CAUDAL ATTEMPTED WITH A 20G CATHETER. ATTEMPT WAS UNSUCCESSFUL AND NEEDLE WITH CATHETER MET RESISTANCE UPON REMOVING. WHEN REMOVING THE IV CATHETER, THE NEEDLE WAS FULLY INTACT, BUT 1.5CM OF THE IV CATHETER WAS MISSING FROM THE CATHETER PULLED OUT. WHAT WAS LEFT OF THE CATHETER WAS FRAYED AT THE END. DR. 3 [REDACTED] DID AN ULTRASOUND IN THE OR AND SAW THE CATHETER LEFT BEHIND SUBCUTANEOUSLY. CARE TEAM MEMBER REACHED OUT TO GENERAL SURGERY MD. DR. 1 [REDACTED] SPOKE WITH IR [INTERVENTIONAL RADIOLOGY] AND PLACED AN ORDER FOR ULTRASOUND IMAGING TO CONFIRM THE LOCATION IS SUBCUTANEOUS. CARE TEAMS CONFIRMED SUBCUTANEOUS LOCATION OF THE 1.3CM CATHETER. FAMILY HAD BEEN NOTIFIED THAT AN ULTRASOUND ORDER WAS PLACED AND WENT TO THE FRONT DESK CONCERNED. FAMILY PLACED IN CONSULT ROOM FOR DR. 1 [REDACTED] TO INFORM THEM OF THE SITUATION. GENERAL SURGERY MD CONSENTED THE FAMILY TO REMOVE THE CATHETER. CATHETER WAS A 20

  Patient problems: Foreign Body In Patient

  MAUDE report 25563575 ↗
• InjuryJun 19, 2026Break

  AS REPORTED BY THE USER FACILITY: CATHETER BROKEN OFF. DESCRIPTION - PIECE OF THE CATHETER BROKE OFF IN THE PATIENTS ARM AND HAD BEEN SURGICALLY REMOVED. PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2023 WHICH IV WAS STARTED. ON (B)(6) 2023 IV WAS REMOVED ONCE PATIENT WAS RELEASED FROM HOSPITAL, HE WAS SENT HOME AND THE PLACE THE IV WAS GOT INFECTED. THEY HAD AN ULTRASOUND DONE AND FOUND A PIECE OF THE CATHETER IN HIS BASILIC VEIN (RIGHT ARM). ON (B)(6) 2023 SURGERY WAS PERFORMED TO REMOVE THE BROKEN PIECE. PATIENT WAS OKAY. MALE 61 UNABLE TO VERIFY WHICH CATHETER BROKE OFF. PART NUMBERS LISTED ARE 4252527-02 & 4251652-02 IN PATIENT RECORD. AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2023-00612, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 18DEC2023. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 25563378 ↗
• MalfunctionJan 6, 2025Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY MEDSUN FORM 3500A (B)(4): DATE OF EVENT: OCT-2024. DESCRIBE THE EVENT OR PROBLEM: AFTER AN UNSUCCESSFUL IV INSERTION, THE SAFETY MECHANISM DID NOT FUNCTION PROPERLY AND DIDN'T COVER THE SHARP TIP OF THE NEEDLE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? IV INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085857 ↗
• MalfunctionMay 1, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER COMPLAINT ADVOCATE RECEIVED A LIVE CALL - CUSTOMER REPORTED THAT ON (B)(6) 2024 THE INTROCAN SAFETY FEP 20G, 1.1X45MM-US WAS INSERTED IN A PATIENT DURING IN THE OPERATING ROOM.  THE PATIENT WAS THEN TRANSFERRED TO THE FLOOR AND TWO TO THREE LATER A NURSE REMOVED THE INTROCAN SAFETY FEP 20G, 1.1X45MM-US FROM THE PATIENT ARM AND THE DEVICE DETACHED.  THE NURSE USED THE PROPER TECHNIQUE WITH ONE HAND APPLIED TO THE PATIENT AND USED THE OTHER HAND TO REMOVE THE DEVICE.  THE PINK HUB CAME OUT OF THE PATIENT BUT THE PLASTIC SHEATH THAT IS ATTACHED TO THE PINK HUB DID NOT COME OUT.  THE PATIENT HAD TO BE SEDATED TO REMOVED THE DETACHED PIECE STILL IN THE ARM.  PATIENT WAS TRANSFERRED BACK THE OPERATING ROOM WHERE THE DEVICE WAS REMOVED.  NOT SURE IF AN INCISION WAS REQUIRED.  LOCAL ANESTHESIA USED AND LIGHT SEDATION (NON ANESTHESIA). THE DEVICE IS NOT AVAILABLE FOR EVALUATION A PHOTO MAY BE AVAILABLE IN ADDED TO THE PATIENT RECORD.

  Patient problems: Foreign Body In Patient

  MAUDE report 19220063 ↗
• InjuryDec 18, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: CATHETER BROKEN OFF. DESCRIPTION - PIECE OF THE CATHETER BROKE OFF IN THE PATIENTS ARM AND HAD BEEN SURGICALLY REMOVED. PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2023 WHICH IV WAS STARTED. ON (B)(6) 2023 IV WAS REMOVED. ONCE PATIENT WAS RELEASED FROM HOSPITAL, HE WAS SENT HOME AND THE PLACE THE IV WAS GOT INFECTED. THEY HAD AN ULTRASOUND DONE AND FOUND A PIECE OF THE CATHETER IN HIS BASILIC VEIN (RIGHT ARM). ON (B)(6) 2023 SURGERY WAS PERFORMED TO REMOVE THE BROKEN PIECE. PATIENT WAS OKAY. MALE 61. UNABLE TO VERIFY WHICH CATHETER BROKE OFF. PART NUMBERS LISTED ARE 4252527-02 & 4251652-02 IN PATIENT RECORD.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 18347163 ↗
• MalfunctionFeb 1, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "IV CATHETER WILL NOT FLUSH OR DRAW BLOOD BACK AFTER SALINE LOCK APPLIED. SAME APPEARED SHEARED AT THE TIP FOLLOWING REMOVAL." NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16277540 ↗
• MalfunctionMar 18, 2019Break; Break

  AS REPORTED BY USER FACILITY: TIP OF AN INTROCAN IV CATHETER BROKE OFF WHEN THE CATHETER WAS BEING REMOVED AND REMAINED IN PATIENT'S VEIN. CATHETER REMOVAL WAS ATTEMPTED ON (B)(6) 2019. THE CATHETER TIP WAS NOT REMOVED FROM THE PATIENT. A CONSULT WITH A VASCULAR SURGEON WAS COMPLETED AND THE PATIENT WAS PROVIDED THE SURGEONS' OFFICE NUMBER FOR FOLLOW UP IN A WEEK OR TWO AND INSTRUCTED TO CALL IF THERE IS REDNESS OR INCREASED PAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8427974 ↗
• MalfunctionApr 20, 2018Break; Break

  AS REPORTED ON MEDWATCH (B)(4): THE PATIENT WAS TRANSFERRED FROM A OUTSIDE USER FACILITY. THE RN HAD TROUBLE FLUSHING THE IV LINE. ATTEMPT TO FLUSH LINE IN THE RIGHT UPPER ARM CAUSED A LOT OF PAIN FOR THE PATIENT. THE LINE COULD NOT BE FLUSHED. THERE WAS A HARD PLASTIC-LIKE BULGE FELT WHERE THE CATHETER SHOULD BE. THE LINE WAS PULLED AND FOUND TO BE VERY KINKED. THE TIP SEEMED TO BE TORN OFF. THE PROVIDER WAS NOTIFIED. A CONCERN FOR THE RETAINED TIP WAS NOTED AND DISCLOSURE TO THE PATIENT WAS DONE. MULTIPLE DIAGNOSTIC EXAMS WERE PERFORMED TO LOCATE THE TIP OF IV LINE. THERE WAS NO VERIFICATION BY AN EXAM THAT THERE WAS A RETAINED FOREIGN OBJECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448735 ↗