INTROCAN SAFETY® 4251890-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963318154), received between Sep 9, 2020 and Feb 25, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 1, 2022Open, Classified

   Potential for leakage at the catheter hub.

   Z-0009-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 13600003 ↗
• MalfunctionSep 9, 2020Break; Break

  AS REPORTED BY USER FACILITY THROUGH MEDWATCH (B)(4): THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND LAID SUPINE ON THE OPERATING TABLE. AFTER ADEQUATE GENERAL ANESTHESIA WAS OBTAINED, THE RIGHT SHOULDER WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A SMALL INCISION WAS MADE AND A LARGE AMOUNT OF PURULENT MATERIAL WAS THEN EVACUATED. THERE DOES APPEAR TO BE EXTENSION DOWN TO THE SHOULDER JOINT JUST ON MANUAL PALPATION WITH THE SUCTION DEVICE. FLUID WAS SENT FOR CULTURE. AT THIS TIME, THE PATIENT WENT INTO CARDIAC ARREST WITH VENTRICULAR FIBRILLATION. ACLS PROTOCOL WAS INITIATED WITH EVENTUAL RETURN OF SPONTANEOUS PULSES AS WELL AS RESPIRATIONS; HOWEVER, I DID NOT PLACE A DRAIN. I MERELY QUICKLY CLOSED THE SMALL INCISION DUE TO THE ONGOING NEED FOR CHEST COMPRESSIONS AND RESUSCITATION. THE PATIENT WAS TAKEN TO THE ICU IN CRITICAL CONDITION. DURING THE RESUSCITATION OF THE PATIENT ON THE AFOREMENTIONED INCIDENT, THE B. BRAUN MEDICAL INC. INTROCAN FEP STRAIGHT SAFETY IV CATHETER 14 GA X 1.25 IN BROKE INSIDE THE PATIENT'S AV FISTULA WHERE THE HUB MEETS THE CATHETER SHAFT. THE BROKEN END WAS NOT RETRIEVED AT THE TIME DUE TO THE PATIENT'S CRITICAL CONDITION. IT IS PRESUMED THAT

  Patient problems: Foreign Body In Patient

  MAUDE report 10507090 ↗