Cook G03120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002031203), received between Jul 3, 2017 and Jan 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (1 report).

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

• MalfunctionJan 21, 2019Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A SINGLE LUMEN CENTRAL VENOUS CATHETER WAS PLACED IN A PATIENT. THE PHYSICIAN ATTEMPTED TO ATTACH AN ICU MEDICAL ¿7¿ SMALL BORE PRESSURE INFUSION EXT SET W/ MICROCLAVE AND REPORTED AIR IN THE LINE. THE PHYSICIAN REPORTED THAT WHEN A NEEDLELESS CONNECTOR WAS ATTACHED TO THE LINE WITH THE IV TUBING, AIR WAS NO LONGER PRESENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8265291 ↗
• MalfunctionJul 3, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A SINGLE LUMEN CENTRAL VENOUS CATHETER. THE CUSTOMER STATES THAT THE DEVICE DID NOT SEAL WITH A THREE-WAY STOPCOCK OR NEEDLELESS INJECTION CAPS. THE PHYSICIAN USED AN ADDITIONAL EXTENSION TUBE TO ACCOMPLISH A SEAL WITH THE DEVICES. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6684661 ↗