DORA BAIN-A.V.F-001SERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 06948082746086), received between Mar 27, 2025 and Apr 30, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT ON A BAIN FISTULA NEEDLE 16GX1, 25MM, A CANNULATED PATIENT WITH AV FISTULA NEEDLE NOTED UPON BLEEDING DOWN THE LINE THERE AS A HOLE IN THE PRODUCT LEAKING BLOOD. REQUIRED NEEDLE TO BE REMOVED. PATIENT RECANNULATED." 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 21934679 ↗
• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT THERE IS MALFUNCTION ON A BAIN FISTULA NEEDLE 16GX1, 25MM. A PATIENT WAS CANNULATED WITH THIS NEEDLE. ONE OF THE NEEDLES HAD A LEAK PRESENT ON THE DISTAL END. THE LEAK WAS BETWEEN THE TUBING AND THE CONNECTOR THAT CONNECTS TO THE LINES. 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 21928896 ↗
• MalfunctionMar 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT ON A BAIN FISTULA NEEDLE 16GX1, 25MM, SLOW BLOOD LEAK THROUGH NEEDLE SOFT TUBING AT HUB CONNECTOR RESULTING IN MODERATE BLOOD LOSS.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 21708082 ↗
• MalfunctionMar 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO INFORMATION FROM MAUDE DATABASE, ONE HEALTHCARE STAFF REPORTED THAT ON A BAIN FISTULA NEEDLE 16GX1, 25MM, A FEW MINUTES AFTER THE PATIENT WAS CONNECTED TO THE MACHINE AND TREATMENT BEGAN, THE PATIENT OBSERVED BLOOD LEAKING FROM THE TUBE. UPON INSPECTION, STAFF NOTED BLOOD COMING OUT BETWEEN THE END OF THE TUBE AND THE TUBE'S LUER LOCK. 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 21707605 ↗