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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06948082700590), received between Nov 20, 2023 and Nov 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2023Device Slipped; Unstable; Device Slipped; Unstable

  A USER FACILITY CLINICAL MANAGER REPORTED VIA EMAIL BAIN-A.V. (B)(4) ON WHICH THE NEEDLES WERE TOO LONG AND DURING USE OF WHICH THE PATIENT INFILTRATED, RUNNING WITH A YELLOW AMP LIGHT. THE COMMENT WAS MADE THAT THE NEEDLES FEEL MORE FLIMSY; A TRAIL OF BLOOD COMES OUT OF THE NEEDLE WHEN THE SAFETY DEVICE IS ENGAGED. GREAT CARE MUST BE TAKEN TO ENSURE THE DEVICE DOES NOT COME OUT THE SIDE OF THE SAFETY DEVICE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Discomfort; Needle Stick/Puncture

  MAUDE report 18175834 ↗