DORA BAIN-A.V.F-009SERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 06948082746109), received between Sep 27, 2024 and Jul 13, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Dull, Blunt

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25795039 ↗
• MalfunctionAug 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT ON A BAIN FISTULA NEEDLE 15GX1, 25MM, THERE WAS A HOLE ON THE FISTULA NEEDLE TUBING, BLOOD WAS VISUALIZED COMING FROM THE FISTULA TUBING.AIR ALARM STARTED TO ALARM AT THE SAME TIME, AIR ENTERED SYSTEM SECONDARY TO BROKEN INTEGRITY OF TUBING. BLOOD WAS UNABLE TO RETURNED, TO INABILITY TO CLEAR AIR FROM VENOUS CHAMBER.THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Exposure to Body Fluids

  MAUDE report 22686940 ↗
• MalfunctionMar 27, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED TO (B)(6) THAT ON A BAIN FISTULA NEEDLE 15GX1, 25MM, CAUSE PATIENTS PAIN WITH CANNULATION AND CLOTTING ISSUES. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Exposure to Body Fluids

  MAUDE report 21708326 ↗
• MalfunctionMar 27, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE REGISTERED NURSE REPORTED THAT ON A BAIN FISTULA NEEDLE 15GX1, 25MM, CAUSE EXTREME PAIN WITH CANNULATION, CAUSING ACCESS CLOTTING ISSUE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21708180 ↗
• MalfunctionMar 27, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT ON A BAIN FISTULA NEEDLE 15GX1, 25MM, CAUSE PATIENTS TO CLOT. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

  Patient problems: Exposure to Body Fluids

  MAUDE report 21708144 ↗
• MalfunctionMar 27, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT ON A BAIN FISTULA NEEDLE 15GX1, 25MM, CAUSE PATIENTS PAIN WITH CANNULATION AND CLOTTING ISSUES.THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Exposure to Body Fluids

  MAUDE report 21707010 ↗
• MalfunctionMar 27, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT ON A BAIN FISTULA NEEDLE 15GX1, 25MM, CAUSE PATIENTS PAIN WITH CANNULATION AND CLOTTING ISSUES.THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Exposure to Body Fluids

  MAUDE report 21706851 ↗
• MalfunctionMar 27, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT ON A BAIN FISTULA NEEDLE 15GX1, 25MM, CAUSE PATIENTS PAIN WITH CANNULATION AND CLOTTING ISSUES. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Exposure to Body Fluids

  MAUDE report 21706797 ↗
• MalfunctionSep 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, A REGISTERED NURSE REPORTED TO (B)(6) THAT ON A BAIN FISTULA NEEDLE 15GX1, 25MM, THERE WAS A SMALL HOLE ON THE TUBING THAT CAUSED BLOOD LEAK UPON CANNULATION."THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

  Patient problems: Exposure to Body Fluids

  MAUDE report 20325987 ↗