Monoject 8881247111Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521020498), received between Feb 14, 2018 and Mar 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE MESC COLLECTION PROCEDURE, THE ASPIRATE NEEDLE WAS INSERTED BY THE OPERATOR AT THE LEVEL OF THE RIGHT POSTERIOR ILIAC CREST, IN ORDER TO PROCEED WITH BONE MARROW BLOOD ASPIRATION. SUBSEQUENTLY, WHEN THE OPERATOR WAS WITHDRAWING THE NEEDLE, THE HANDLE OF THE DEVICE DISENGAGED FROM THE NEEDLE AND REMAINED STUCK IN THE THICKNESS OF THE BONE. IN A FEW MINUTES, USING KLEMMER FORCEPS, IT WAS POSSIBLE TO REMOVE THE NEEDLE FROM THE BONE SEAT, AND CONTINUE WITH THE COLLECTION PROCEDURE USING OTHER NEEDLES FROM THE SAME BATCH, WITHOUT FURTHER INCIDENTS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545790 ↗
• MalfunctionFeb 14, 2018Break; Break

  THE CUSTOMER REPORTS THE HANDLE ON ONE OF THE NEEDLES BROKE AND THE SECOND NEEDLE BENT DURING THE BONE MARROW ASPIRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7270146 ↗