MEDLINE 6012498502Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10197344014231), received between Mar 10, 2026 and Mar 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Damaged Thread” (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.

• MalfunctionMar 12, 2026Damaged Thread

  "THE CUSTOMER REPORTED THAT "BLUE 20ML SYRINGES ARE NOT THREADING PROPERLY AND AIR IS ENTERING INTO THE MANIFOLD." NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584458 ↗
• MalfunctionMar 10, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT, "BLUE 20ML SYRINGES ARE NOT THREADING PROPERLY AND AIR IS ENTERING INTO THE MANIFOLD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559360 ↗