DeRoyal 89-7059Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756735674), received between Oct 18, 2018 and Oct 18, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2018Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  THE 20ML LUER LOCK SYRINGE CONTAINED IN THE CONVENIENCE KIT IS LEAKING AND THE PLUNGER IS LOOSE. AIR IS GETTING INTO THE LINE WHEN PUSHING FLUIDS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7978634 ↗