DeRoyal 89-9002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756895323), received between Nov 21, 2018 and Nov 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 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

  THE BLUNT NEEDLE PACKAGED IN A CONVENIENCE KIT POPPED OFF DURING INJECTION INTO THE SPINAL CAVITY. WHEN UNDER PRESSURE, THE NEEDLE WILL POP OFF, RESULTING IN LOST MEDICATION. THE PHYSICIAN DOES NOT KNOW HOW MUCH PAIN MEDICINE LEAKED OUT, AND THEREFORE, THE PATIENT MAY NOT BE RECEIVING THE PROPER AMOUNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096459 ↗