Monoject 8881400058Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521002620), received between Nov 5, 2019 and May 12, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT WHEN SCREWING THE NEEDLES INTO THE SYRINGE, THE NEEDLE IS LOOSE AND WOBBLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815799 ↗
• MalfunctionMay 12, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT WHEN SCREWING THE NEEDLE INTO THE SYRINGE, THE NEEDLE IS LOOSE AND WOBBLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815734 ↗
• MalfunctionNov 5, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE NEEDLE WAS BREAKING OFF. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE HUB WAS STRIPPING AND FALLING OFF FROM THE SYRINGE, WHEN THEY TRIED TO USE THE SYRINGE. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279360 ↗