Irrigation Set 313003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964175794), received between Oct 2, 2019 and Sep 28, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 28, 2020Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT WHEN ASSESSING THE PATIENT AND CBI THE RN NOTICED THAT THERE WAS SOMETHING IN THE TUBING, WHEN SHE PINCHED IT SHE REALIZED IT WAS HARD, NOT SEDIMENT. THE CBI WAS STOPPED, TUBING DISCONNECTED, AND FLUSHED. THE PARTICLE OF PLASTIC WAS THE TIP OFF THE SPIKE. NEW TUBING WAS USED TO CONTINUE CBI. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10592463 ↗
• MalfunctionOct 2, 2019Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILITY: "SURGEON REPORTED THAT WHILE USE OF THE SET, THERE WERE BUBBLES COMING DOWN THE SET THAT WERE OBSTRUCTING THE FIELD. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9145708 ↗