DORA BAIN-A.V.F-009SGRecalls & reported problems
Bain Medical Equipment (Guangzhou) Co., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06948082700675), received between Nov 20, 2023 and Nov 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REGISTERED NURSE(RN) REPORTED VIA FAX THAT THERE WAS BLEEDING AROUND THE VENOUS BAIN NEEDLE SITE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18176159 ↗
Other Needle, Fistula devices
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5002-33Jms Singapore Pte Ltd · Needle, Fistula6 deaths27 reports
- DORA BAIN-A.V.F-009SEBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula9 reports
- DORA BAIN-A.V.F-001SEBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula4 reports
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-7005-33Jms Singapore Pte Ltd · Needle, Fistula2 deaths4 reports
- NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER 15GX1" HTC-30W-D-CAPNipro Medical Corporation · Needle, fistula2 reports
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5003-33Jms Singapore Pte Ltd · Needle, Fistula1 report
- JMS HARMONY A.V.FISTULA NEEDLE SET 827-1500-33Jms Singapore Pte Ltd · Needle, Fistula1 report
- DORA BAIN-A.V.F-001SGBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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