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

Model Number BAIN-A.V.F-009SG

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

1.Background: when checking product complaint information on fda website, we found 46 complaints of products produced by bain medical equipment (guangzhou) co., ltd, of which 45 cases were about puncture needle products and 1 was about blood tube product.The report date of these complaints on fda official website is august 12,2023, and the date we got these complaints on fda official website is october 13, 2023.2.Event classification and confirmation: among the 45 cases of puncture needle products, 34 cases were confirmed as abnormal puncture points, mainly blunt needle, difficult to puncture, patient pain and puncture point bleeding; 10 cases of protective shield and one blood leakage case of cap for fll (female luer lock).And this report is mainly 34 cases of abnormal puncture points.(mw5131521, mw5131678, mw5131833, mw5132297, mw5132533, mw5132957, mw5134002, mw5134268, mw5135510, mw5135567, mw5135710, mw5135839, mw5136046, mw5136107, mw5136737, mw5136855, mw5136914, mw5138152, mw5138296, mw5139533, mw5140085, mw5140140, mw5140598, mw5140860, mw5141492, mw5141977, mw5142086, mw5142327, mw5142764, mw5143229, mw5143364, mw5143481, mw5143505, mw5144427).3.Confirmation of abnormal puncture point events: confirming the information of each reported case on the website, including the checking of product model, batch number, reporting time and content, and finding out the corresponding complaints we have received.34 abnormal puncture point events occurred in 2020, and 2 events occurred in 2021.Among 32 events occurred in 2020, there were 3 events (fda report number mw5132533/mw5142086/mw5142327) that we has not received any complaint information from end users or distributor.4.Evaluation of abnormal puncture point events: the abnormality of the puncture point will not cause serious harm to the patient, and the recurrence of similar events will not cause serious harm to the patient too, the reasons are as follow: the bleeding point is located in the needle puncture position, which will not cause serious harm to the patient; because there is skin wrapping around the needle, the bleeding point area is tiny, bleeding volume is low , and the position is obvious(easy to discover in time); the problems for the patient feels pain or the nursing staff feels that the needle tip is blunt and difficult to puncture which are subjective feelings and occurring in the operation process, which are monitored by professionals, and will not cause serious harm to the patients.Information from the 34 events can be confirmed that the puncture point abnormality caused no serious injury to the patient.Following the definition of serious injury in[ 21cfr803.3 (c) and guidance for industry and food and drug administration staff (2.13)], we believe that the puncture point abnormal event did not meet the serious injury event, therefore we consider the 34 puncture point abnormal events need not be reported to the fda.This report is made out of an abundance of caution.5.Investigations and analyses of abnormal events: 5.1 there may be these product factors which result in the puncture point abnormality: include the dimension of the needle tips did not match the drawing, appearance problems like bent and burrs tips ,and poor silicified needle tips which lead to rough needle tips.We have conducted a full investigation from the production process records, final inspection records and retention samples of the complaint batches (18 batches in total) ,by checking the dimension\appearance\puncture force, no abnormality was found.According to the result of investigation, the dimension of the needle tips matched the drawing, there was no appearance problems like bent and burrs tips or poor silicified needle tips.Among 32 events occurred in 2020, there were 3events (fda report numbermw5132533/mw5142086/mw5142327) that we did not received any complaint information from end users or distributor, and 3 years have already passed, relevant information, including product and clinical information cannot be investigated.In addition, the us market was the first time to use our products, in 2020 we had communicated with distributor and they believed that dialysis centers in the united states used other puncture needles in the past, so some health professional needed time to adapt to the new one in clinical use,we confirm that code 5484 dialysis center complained 7 times, code 2376 dialysis center complained 5 times, both code 6322 and 7252 dialysis center complained 2 times, each of the rest dialysis center complained only once.Distributor said they would strengthen communication with the complaint center in july 2020 to ensure the smooth use of the product.From 2021 to 2023, we tracked the complaints in 5484 and 2376 dialysis centers, and found no further complaint in these two centers.Therefore, puncture point abnormalities are mainly related to the adaptability of clinical use.5.2 analyze the abnormal factors of puncture point, main factors include 5.2.1.Puncture point abnormality-likelihood analysis of the bleeding at the puncture point (a) injury of blood vessel: the needle may damage the vessel during the puncture.This condition is usually accompanied by bleeding and may require emergency management to stop bleeding.(b) bleeding tendency: some people may be more prone to puncture bleeding due to bleeding tendency or coagulation disorder.This may be due to platelet dysfunction, defective coagulation factors, or other blood diseases.(c) needle choice: selecting inappropriate needle or using of improper puncture technique may increase the risk of bleeding.(d) insufficient puncture depth: it may also lead to bleed if the needle does not get into the vessel but simply pierce the surface of the vessel or the surrounding tissue.(e) patient factors: like blood pressure, body position, skin conditions and vascular conditions may also increase the risk of bleeding.(f) movements during treatment:after needle punctured, patient's or operator's carelessly moving or shaking the needle may also cause bleeding.(g) inflammation or infection: sometimes, inflammation or infection around the puncture site which cause local vessels expansion or increased blood flow,can bring bleeding.5.2.2.Puncture point abnormality-likelihood analysis of the pain and difficulty of puncturing (a) needle choice: selecting inappropriate needle or size may cause puncture pain.The needle should be selected according to the patient details and needs to ensure correct puncture and proper blood flow.(b) improper puncture skills: may cause pain and difficult puncture,improper puncture skills include improper puncture angle, depth or speed, and incorrect manipulation that may cause tissue damage or inflammation during puncturing the needle.(c) overactive and unstable vessel: ]vessels of some patients may be overactive and not stable[?]which may make puncture more challenging, and easily cause some subjective feelings like difficulty of puncture and pain.(d) local infection or inflammation: if there is infection or inflammation near the puncture site, this may lead to a difficult puncture and a painful sensation during the puncture.(e) bleeding tendency: bleeding tendency or coagulation disorder may lead to increased bleeding after the puncture, and lead to pain.(f) patients' anxiety and nervousness: anxious and nervous patients may more likely feel the pain, because their muscles may be tenser ,which may increase the difficulty and discomfortable feelings in puncturing.(g) site of puncture: different sites may cause different pain feelings.Different nerve distribution in different sites, and areas with more nerve lines may be more sensitive than other parts, and patients are susceptible to pain.(h) excessive frequent puncture: if the patient needs frequent dialysis, frequent puncture may lead to injury to the puncture site, increasing the risk of pain.6.Onclusion 6.1after assessing the events, we confirmed that these 34 cases were not serious injury events and did not need to be reported to the fda.This report is made out of an abundance of caution.6.2 when we received relevant complaints, we made investigations immediately, to confirm that the quality of products corresponded with the requests, and submitted the investigation results to distributor, and no other comments received for the investigation results, so the relevant events were closed.In addition, after strengthening communication between the distributor and the dialysis centers, in these centers with more complaints, which we have tracked for 3 years, no more relevant complaints appear again.Therefore, we consider the puncture point abnormality is related to the adaptability about the health professional using new product.

Event Description

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).

• Brand Name: DORA
• Type of Device: DISPOSABLE A.V. FISTULA NEEDLE SETS
• Manufacturer (Section D): BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.; no.10, juncheng road; eastern zone, getdd; guangzhou, guangdong 51076 0; CH 510760
• Manufacturer (Section G): BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.; no.10, juncheng road, eastern; economic&technology develop; guangzhou, guangdong 51076 0; CH 510760
• Manufacturer Contact: zoe zeng ; no.10, juncheng road, eastern zone,; economic&technology development; guangzhou, guangdong 51076-0 ; CH 510760
• MDR Report Key: 18176159
• MDR Text Key: 328616901
• Report Number: 3013217742-2023-00001
• Device Sequence Number: 1
• Product Code: FFI
• UDI-Device Identifier: 06948082700675
• UDI-Public: 06948082700675
• Combination Product (y/n): N
• PMA/PMN Number: K163025
• Number of Events Reported: 34
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2023
• Device Model Number: BAIN-A.V.F-009SG
• Device Lot Number: 202002010541
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1