One-Step™ 00884450537336Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00884450537336), received between Sep 15, 2022 and Sep 20, 2022 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15458700 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432716 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432712 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432697 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FROM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432695 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FROM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432694 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432691 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432690 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FROM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432689 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432686 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432684 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FROM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432678 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432670 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FROM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432666 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432663 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FROM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432616 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432612 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432611 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE PROCEDURE AFTER THE STYLET IS REMOVED FORM THE ACCESS NEEDLE FLUID WILL LEAK FROM THE VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432607 ↗