INTROCAN SAFETY® 4252535-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04046963165925), received between Jan 26, 2018 and Apr 29, 2024 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (16 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: THE NEEDLE BROKE IN THE PATIENT ANGIO SHEARED FROM THE NEEDLE PATIENT WAS FINE BUT COMPLAINING OF PAIN.

  Patient problems: Pain

  MAUDE report 19200829 ↗
• MalfunctionJun 6, 2022Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: SAFETY FEATURE ON NEEDLE DOES NOT WORK PROPERLY. PLEASE NOTE THAT THE INITIAL REPORT WAS SUBMITTED ON (B)(6) 2022 VIA THE INCORRECT REPORT NUMBER (B)(6); HOWEVER, THE REPORT WAS SUBMITTED ON TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603621 ↗
• MalfunctionMay 26, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: BLOOD LEAKS FROM THE LIP OF THE NEEDLE WHEN DRAWN SINCE THE PLASTIC COMPONENT IS BROKEN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517902 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE A DIVET/PIECE WAS MISSING AND BLOOD STARTED LEAKING OUT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348184 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT BLOOD LEAKED AROUND THE PINK HUB. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348168 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT BLOOD LEAKED AROUND THE PINK HUB. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348167 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT BLOOD LEAKED AROUND THE PINK HUB. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348166 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT BLOOD LEAKED AROUND THE PINK HUB. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348163 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 5: IT WAS REPORTED THAT BLOOD LEAKED AROUND THE PINK HUB. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348160 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 6: IT WAS REPORTED THAT BLOOD LEAKED AROUND THE PINK HUB. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348159 ↗
• MalfunctionApr 11, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE SEAL OF THE CATHETER IS DEFECTIVE. WE HAD TO PLACE IV'S SEVERAL TIMES ON SEVERAL DIFFERENT PATIENTS AND THEY WERE LEAKING ALL OVER THE PT. WE THOUGHT IT WAS THE TRANSFER DEVICE FOR BLOOD AT FIRST BECAUSE WE COULD NOT GET SUCTION TO DRAW THE BLOODS. THEN WE TRIED PUTTING THE EXTENSION TUBE TO THE CATHETER AND IT WAS LEAKING ALL OVER. WE TRIED ALL THE DIFFERENT LOT NUMBER OF THE 20G AND THIS PARTICULAR LOT NUMBER WAS THE ONLY DEFECTIVE ONES. NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14075125 ↗
• MalfunctionApr 11, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE SEAL OF THE CATHETER IS DEFECTIVE. WE HAD TO PLACE IV'S SEVERAL TIMES ON SEVERAL DIFFERENT PATIENTS AND THEY WERE LEAKING ALL OVER THE PT. WE THOUGHT IT WAS THE TRANSFER DEVICE FOR BLOOD AT FIRST BECAUSE WE COULD NOT GET SUCTION TO DRAW THE BLOODS. THEN WE TRIED PUTTING THE EXTENSION TUBE TO THE CATHETER AND IT WAS LEAKING ALL OVER. WE TRIED ALL THE DIFFERENT LOT NUMBER OF THE 20G AND THIS PARTICULAR LOT NUMBER WAS THE ONLY DEFECTIVE ONES. NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14075111 ↗
• MalfunctionApr 11, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE SEAL OF THE CATHETER IS DEFECTIVE. WE HAD TO PLACE IV'S SEVERAL TIMES ON SEVERAL DIFFERENT PATIENTS AND THEY WERE LEAKING ALL OVER THE PT. WE THOUGHT IT WAS THE TRANSFER DEVICE FOR BLOOD AT FIRST BECAUSE WE COULD NOT GET SUCTION TO DRAW THE BLOODS. THEN WE TRIED PUTTING THE EXTENSION TUBE TO THE CATHETER AND IT WAS LEAKING ALL OVER. WE TRIED ALL THE DIFFERENT LOT NUMBER OF THE 20G AND THIS PARTICULAR LOT NUMBER WAS THE ONLY DEFECTIVE ONES. NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14075109 ↗
• MalfunctionApr 4, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1. IT WAS REPORTED THAT THE PATIENT'S BLOOD LEAKED AT THE HUB OF THE NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994484 ↗
• MalfunctionApr 4, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3. IT WAS REPORTED THAT THE PATIENT'S BLOOD LEAKED AT THE HUB OF THE NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994479 ↗
• MalfunctionApr 4, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2. IT WAS REPORTED THAT THE PATIENT'S BLOOD LEAKED AT THE HUB OF THE NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994478 ↗
• MalfunctionApr 4, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 4. IT WAS REPORTED THAT THE PATIENT'S BLOOD LEAKED AT THE HUB OF THE NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994476 ↗
• MalfunctionMar 15, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION "UPON INSERTION OF IV CATHETER AND ATTACHMENT OF VACUETTE BLOOD NOTED TO BE LEAKING AROUND VACUETTE AND CATHETER HUB." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13774660 ↗
• 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 13599955 ↗
• MalfunctionFeb 9, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER STATES "IV CATHETER IN HIS RIGHT FOREARM BECOME DISLODGED. CATHETER WAS BROKEN DIRECTLY OFF AT THE HUB". AN ULTRASOUND OF THE RIGHT ARM, RIGHT ARM X-RAY AND CHEST X-RAY WAS COMPLETED. HE WAS DISCHARGED THE FOLLOWING DAY WITH NO FINDINGS, NO PROCEDURES OR COMPLICATIONS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497642 ↗
• MalfunctionJun 25, 2021Break; Break

  AS REPORTED THROUGH MW (B)(4): REGISTERED NURSE (RN) ASSESSED THE POSITIONING OF AN INTROCAN SAFETY® IV CATHETER 20G X 1.25 FEP (S) PT'S ON LEFT HAND NEAR WRIST OF PATIENT REALIZING THAT IV SITE NOT FLUSHING. RN REMOVED THIS INTROCAN SAFETY® IV CATHETER 20G. THE SITE OF THE PATIENT'S IV CATHETER 20G THAT WAS ON LEFT HAND NEAR WRIST HAD A DRESSING THAT OVERLAPPED WITH ANOTHER IV CATHETER 20G SITE DRESSING LOCATED ON THE LEFT LOWER FOREARM. RESISTANCE WAS NOT MET WHEN INTROCAN SAFETY® IV CATHETER 20G ON LEFT HAND NEAR WRIST WAS REMOVED. IV CATHETER THAT WAS REMOVED FROM PATIENT WAS COMPARED TO AN UNUSED 20G IV CATHETER AND MEASURED BY CHARGE RN. IT WAS FOUND THAT 2 CM OF THE USED IV CATHETER WERE MISSING. ORDERS WERE RECEIVED FOR VENOUS ULTRASOUND OF LEFT EXTREMITY. PATIENT STATED THAT PAIN ON HIS LEFT EXTREMITY IS A 0/10 AT THIS TIME. ORIGINAL PACKAGING HAD BEEN DISCARDED. PATIENT HAD RADIOLOGY STUDIES WHICH SHOWED THE BROKEN PIECE MAY BE LODGED HIGHER IN THE VENOUS SYSTEM. VASCULAR CONSULT DONE AND SURGEON RECOMMENDED THAT THE PIECE BE LEFT WHERE IT IS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12067090 ↗
• MalfunctionJun 1, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CLEANUP AFTER COMPLETING AN IV INSERTION, THE NURSE WAS PUNCTURED ON THE RIGHT INDEX FINGER. THE SAFETY CLIP WAS NOT FULLY COVERING THE TIP OF THE NEEDLE. NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10105962 ↗
• MalfunctionAug 21, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY THE USER FACILITY: THIS REPORT IS FOR EVENT 1: CUSTOMER REPORTS, "WE EXPERIENCED TWO NEEDLE STICK INJURIES WHILE USING INTROCAN SAFETY IV CATHETER." THE CATHETERS INVOLVED WERE EITHER AN 18G (LOT:18B12G8274) OR 20G (LOT: 0061594687). EVENT 1: AFTER IV START THE PROVIDER WAS HOLDING THE UNIT IN THEIR HAND WITH THE SAFETY ENGAGED AND SUSTAINED A "BUMP" AND THE SAFETY DISENGAGED AND IMPALED THE PROVIDER THROUGH THEIR GLOVE. EVENT 2: THE INCIDENT INVOLVING THE 18G CATHETER WILL BE REPORTED VIA REPORT NUMBER 9610825-2019-00375. WHILE CARRYING A TRASH BAG THE PROVIDER WAS IMPALED WITH A USED UNIT. UPON EXAMINATION THE UNIT'S SAFETY DEVICE WAS NOT ENGAGED, RATHER HALF-WAY BACK ON THE STYLET.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8917062 ↗
• MalfunctionDec 10, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: PATIENT HAD A SEPTOPLASTY AND SMR AT THE ENT SURGERY CENTER WHERE HE HAD AN IV CATHETER PLACE IN THE LEFT WRIST. IV WAS DISCONTINUED THAT DAY AND REMOVED POST-SURGERY. 11 DAYS LATER THE PATIENT WENT TO THE EMERGENCY ROOM. THE PATIENT STATED IN THE ER, AN ULTRASOUND WAS PERFORMED AND SHOWED A RETAINED IV CATHETER IN THE LEFT WRIST. HE WAS REFERRED TO AN ORTHOPEDIC SURGEON. THE ADMINISTRATOR STATED HE HAD NO IDEA THE PATIENT HAD COMPLAINED OF PAIN IN HIS LEFT WRIST. THE PATIENT CAME IN FOR SURGERY ON (B)(6) 2018 FOR A SEPTOPLASTY WITH SMR. PATIENT HAD A SUCCESSFUL PROCEDURE. THE NURSE WHO PLACED THE IV IN THE LEFT WRIST WAS SUCCESSFUL AND WITNESSED BY THE ADMINISTRATOR. THE SAME NURSE REMOVED THE IV POST-SURGERY. THE NURSE REPORTED THAT THE IV WAS INTACT WHEN REMOVED. THERE WAS NO RESISTANCE, NO COMPLICATIONS NOTICED. PATIENT HAD NO SIGNS OR SYMPTOMS OF PHLEBITIS OR OTHER ILL EFFECTS FROM THE IV CATHETER. PATIENT WAS LATER DISCHARGED WITH NO COMPLICATIONS FROM THE IV OR SURGERY. THE PATIENT CONFIRMED THAT HE WENT TO THE EMERGENCY ROOM 11 DAYS LATER WITH COMPLAINTS OF SIGNS AND SYMPTOMS OF PHLEBITIS. THE EMERGENCY ROOM DID AN ULTRASOUND AND NOTED A CA

  Patient problems: Foreign Body In Patient; Vasculitis

  MAUDE report 8148477 ↗
• MalfunctionJul 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: AFTER THE CATHETER WAS ENTERED INTO THE PATIENT, THE CATHETER LEAKED DUE TO A SMALL HOLE NEAR THE PLASTIC CAP.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7686107 ↗