Single Use Injector NM-221C-0427Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170414978), received between Jun 7, 2023 and Jan 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124863 ↗
• MalfunctionMay 14, 2024No Device Output; No Device Output

  IT WAS REPORTED THE SINGLE USE INJECTOR FAILED TO INJECT DURING THE DIAGNOSTIC CYSTOSCOPY PROCEDURE AS THE TUBING WAS KINKED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315367 ↗
• MalfunctionJun 16, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THEY HAD AN OUT OF BOX FAILURE WITH THE SINGLE USE INJECTOR ENDOSCOPIC INJECTION NEEDLE WHERE THE USERS TRIED TO INJECT THE NEEDLE AND IT WOULD NOT GO DEEP ENOUGH INTO THE TARGET TISSUE. THE ISSUE WAS FOUND DURING A THERAPEUTIC BLADDER BOTOX PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS A DELAY IN THE PROCEDURE; THE PROCEDURE WAS PERFORMED WITH LOCAL ANESTHESIA AND THERE WAS NO HARM TO THE PATIENT OR USER ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148376 ↗
• MalfunctionJun 7, 2023Infusion or Flow Problem; Infusion or Flow Problem

  A CUSTOMER REPORTED TO OLYMPUS, A NURSE WAS UNABLE TO INJECT BOTOX INTO THE SINGLE USE INJECTOR. WHEN THE DEVICE WAS REMOVED A SMALL KINK AT THE TOP OF TUBING WAS FOUND. THE EVENT OCCURRED DURING A THERAPEUTIC INJECTION OF BOTOX INTO BLADDER. THE PROCEDURE WAS DELAYED FOR 2 MINUTES AND COMPLETED BY REPLACING THE DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083634 ↗