Safedraw™ 10884450409012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450409012), received between Apr 29, 2020 and Mar 11, 2025 — classified as 3 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 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.

• MalfunctionMar 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE TUBE BROKE IN THE A-LINE USED IN THE EMERGENCY WARD. THE BLOOD PRESSURE TUBE, WHICH HAD BEEN IN PLACE FOR ABOUT TWO WEEKS, BROKE AND THERE WAS BLEEDING FROM THE BROKEN AREA. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21578794 ↗
• MalfunctionMay 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING AT A STOPCOCK LOCATED NEXT TO THE PLANECTA. NO PATIENT INJURY TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10033636 ↗
• MalfunctionApr 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGED THAT FLUID WAS FOUND TO BE LEAKING FROM THE PLANECTA DURING A CARDIAC SURGERY. THE PHYSICIAN PATCHED THE LEAK AND CONTINUED THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10012248 ↗