MAUDE Adverse Event Report: BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD. DORA; DISPOSABLE A.V. FISTULA NEEDLE SETS

Model Number	BAIN-A.V.F-009SE
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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).
Additional Manufacturer Narrative
1.Customer communication: on june 5, 2025, the distributor gave feedback that they received a complaint from fresenius medical care regarding blood leaking from fistula tubing due to a hole on the fistula needle tubing.The batch under complaint is (b)(4).However, there were no details for this complaint, thus below questions were raised to the distributor and the below reply was received.1.Was a sample picture or video available? yes.2.Kindly mark the broken spot on the drawing attached.N/a.3.Was there any blood loss, kindly indicate the volume.250ml.4.Was there any serious patient or medical interaction involved? no.5.Had this issue been reported to the fda? no.6.Had the sample involved been disposed of? no sample available.2.Production lot record investigation.No complaint related non-conformances or capas was found during the batch review investigation.3.Retained sample test: 3.1 the information of primary package is confirmed to be complaint with drawing requirements.The appearance of a.V.Fistula needle set is confirmed that there is no tubing damage.3.2 fill the fistula needle with water at (36-38) degree celsius, seal one side of the needle, and apply a positive pressure of 100kpa (750mmhg) to the other side for at least 10mins, and then visually inspect the fistula needle.There is not any leakage on the fistula needle.4.Root cause analysis: reviewing our complaint history, the probability for tubing with small hole is low.Most of these defective can be detected during saline priming process.The customer complained that there was a small hole on the tubing that caused an external blood leakage upon cannulation.We analyze from five aspects: man, machine, material, method and environment.Man: the a.V.F needle is assembled by an automated device and inspected by an inspector.The inspector may not have detected the tubing damaged.Machine: the a.V.F needle is assembled by an automated device.During assembly, there will be some mechanical hands to pick up the tubing.We suspect that the mechanical hands may hurt the tubing when it is picked up due to accidental fluctuations in the equipment.Material: it has nothing to do with that factor.Method: it has nothing to do with that factor.Environment: it has nothing to do with that factor.Based on the above analysis, we suspect that the cause of tubing damage may be the mechanical hands hurt the tubing when it is picked up due to accidental fluctuations in the equipment.The inspector may not have detected the tubing damaged.This is a very rare occurrence.We have checked all the mechanical hands to make sure that they are free of burrs, that the tubing is not damaged during closure.We have increased the inspection frequency of the manipulator from once a quarter to once a month and added it to the monthly inspection items.We will conduct training for all inspection personnel, focusing on tubing holes.In addition, it is suggested that when using dora disposable a.V.Fistula needle sets(safety needle series), pleas refer to instruction for use.5.Direction for use: screw out cap from female luer lock, and fill up tubing with normal saline to exclude air inside.6.Precautions in use: during insertion and intermittently during the treatment, perform visual inspection of the needle and connections to blood tubing with particular attention to blood leaks.Do not cover the insertion site or needle/tubing connection part with blanket or clothes to reduce accidental disconnection.Note that variability in luer connectors and blood lines may predispose them to blood leakage or separation of the needle from the connector.Ensure that the male and female luer connectors are intact by visual inspection.If this product can not be tightly connected or presence of air bubbles and no improvement is achieved, please replace it with another new product.Any abnormal condition should be properly treated under the direction of physician.7.Warning: accidental disconnection of needles from the blood lines may not result in an alarm by the hemodialysis machine.Since disconnection may result in significant blood loss and cause patient injury or death, observe for blood or air leaks.If leaks are detected, stop the treatment immediately.

• Brand Name: DORA
• Common Device Name: DISPOSABLE A.V. FISTULA NEEDLE SETS
• Manufacturer (Section D): BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.; no.10, juncheng road, eastern; guangzhou, guangdong 51070 0; CH 510700
• Manufacturer (Section G): BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.; no. 10,juncheng road,eastern a; guangzhou, guangdong 51070 0; CH 510700
• Manufacturer Contact: sophia shao ; no. 10,juncheng road,eastern area,guangzhou econom; guangzhou, guangdong 51070-0 ; CH 510700
• MDR Report Key: 22686940
• Report Number: 3013217742-2025-00011
• Device Sequence Number: 18503575
• 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,Distributor
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BAIN-A.V.F-009SE
• Device Lot Number: 2402102093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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