One-Step™ 00884450032893Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450032893), received between Mar 24, 2022 and Mar 24, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• InjuryMar 24, 2022Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CENTESIS PROCEDURE, THE HUB DETACHED FROM THE DRAINAGE CATHETER AFTER ACQUIRING ACCESS. NO PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13874093 ↗
• InjuryMar 24, 2022Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CENTESIS PROCEDURE, THE HUB DETACHED FROM THE DRAINAGE CATHETER AFTER ACQUIRING ACCESS. NO PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13874016 ↗
• InjuryMar 24, 2022Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CENTESIS PROCEDURE, THE HUB DETACHED FROM THE DRAINAGE CATHETER AFTER ACQUIRING ACCESS. NO PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873811 ↗