One-Step™ 00884450092750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450092750), received between Oct 7, 2022 and Oct 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.

• MalfunctionOct 18, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A THORACENTESIS PROCEDURE, AFTER GAINING ACCESS AND USING A 60ML SYRINGE TO PULL A SAMPLE, THE VALVE CAME OFF WHEN REMOVING THE SYRINGE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957721 ↗
• MalfunctionFeb 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415035 ↗
• MalfunctionNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844342 ↗
• MalfunctionOct 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER ALLEGES THE DEVICE WAS LEAKING DURING USE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563999 ↗