DeRoyal 89-9920Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756949927), received between Jul 20, 2018 and Mar 29, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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.

• MalfunctionMar 29, 2019Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  THERE WAS A SHARP EDGE ON THE FLANGE OF A SYRINGE. WHEN PUSHING THE PLUNGER IN, A TECHNICIAN WAS STUCK WITH THE SHARP EDGE, CAUSING BLEEDING AND CONTAMINATING THE GLOVE. THIS OCCURRED DURING A PROCEDURE. THE AFFECTED SYRINGE WAS PACKAGED IN A CONVENIENCE KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8464727 ↗
• MalfunctionJul 20, 2018Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion

  AN EMPLOYEE WAS INJURED FROM BURRS ON THE PLUNGER WINGS OF A SYRINGE. THE BURR RIPPED THROUGH TWO PAIRS OF GLOVES AND CUT THE SKIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707922 ↗