Safedraw™ 10884450372514Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450372514), received between Mar 25, 2020 and Jul 9, 2020 — 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 18, 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.

• MalfunctionJul 9, 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 FLUID. AIR INGRESS FROM A PLANECTA STOPCOCK WAS FOUND AFTER A PATIENT WAS TRANSFERRED FROM OPERATING ROOM TO ICU. CRACK COULD NOT BE FOUND DURING VISUAL OBSERVATION. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10254616 ↗
• MalfunctionMay 14, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, A PRESSURE LINE TUBE BROKE OFF DURING USE. THE CIRCUIT WAS REPLACED, AND THE PROCEDURE CONTINUED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10059717 ↗
• MalfunctionMar 25, 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 Known Impact Or Consequence To Patient

  MAUDE report 9881120 ↗