MAUDE Adverse Event Report: BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD. NO.10 BAIN FISTULA NEEDLE 15GX1, 25MM; DISPOSABLE A.V. FISTULA NEEDLE SETS, PRODUCT CODE: FIE

Model Number	BAIN FISTULA NEEDLE 15GX1, 25MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction

• Brand Name: BAIN FISTULA NEEDLE 15GX1, 25MM
• Common Device Name: DISPOSABLE A.V. FISTULA NEEDLE SETS, PRODUCT CODE: FIE
• Manufacturer (Section D): BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD. NO.10; no.10, juncheng road, eastern; guangzhou, guangdong 510700, c; guangzhou 71360
• Manufacturer (Section G): BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD; no.10,juncheng road,eastem a; guangzhou,guangdong 510700.chn; guangzhou, china 51070 0; CH 510700
• Manufacturer Contact: zoe zeng ; no. 10,juncheng road,eastern area,guangzhou econom; guangzhou, guangdong 510700, chn; guangzhou, china 51070-0 ; CH 510700
• MDR Report Key: 25795039
• Report Number: 3013217742-2026-00001
• Device Sequence Number: 8999711
• Product Code: FIE
• UDI-Device Identifier: 06948082746109
• UDI-Public: 06948082746109
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K213015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BAIN FISTULA NEEDLE 15GX1, 25MM
• Device Lot Number: 2502100485
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown