DeRoyal 89-9753Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756936057), received between Dec 5, 2018 and Dec 5, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• MalfunctionDec 5, 2018Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Detachment of Device or Device Component; Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Detachment of Device or Device Component

  WHEN THE SYRINGE IS USED IN TIGHT SPINAL AREAS, THE PRESSURE WOULD POP THE EXTENSION SET OFF, CAUSING LOSS OF MEDICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134107 ↗
• MalfunctionDec 5, 2018Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Detachment of Device or Device Component; Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Detachment of Device or Device Component

  WHEN THE SYRINGE IS USED IN TIGHT SPINAL AREAS, THE PRESSURE WOULD POP THE EXTENSION SET OFF, CAUSING LOSS OF MEDICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134100 ↗