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

Model Number BAIN-A.V.F-001SG

Device Problems Device Slipped (1584); Unstable (1667)

Patient Problems Discomfort (2330); Needle Stick/Puncture (2462)

Event Date 07/30/2020

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, pain and puncture point bleeding; 10cases of protective shield and one blood leakage case of cap for fll(female luer lock).And this report is cases for protective shield and blood leakage of cap for fll.(mw5130686, mw5132714, mw5134596, mw5135982, mw5136110, mw5137862, mw5138895, mw5139576, mw5139998, mw5142087, mw5142779) 3.Confirmation of events for protective shield and cap for fll: 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.The event for fda report number mw5132714 was about blood leakage from cap for fll.10cases of protective shield and one blood leakage case of cap for fll occurred in 2020.4.Evaluation of events for protective shield and cap for fll: a.We had tested protective shield in clinical use according to fda guidelines (medical devices with sharps injury prevention features) and confirmed that protective shield has the function of wrapping needle and preventing needle from exposing and stabbing the user.B.Based on ifu for disposable a.V.Fistula needle sets (safety needle series).6(3) & (4) 3)screw out the cap for female luer lock, pick out needle guard , and fully fill the needle set with normal saline to move out air inside tubing.4)hold the wing, and puncture the vein.Clamp-off the tubing once the blood flows into it.However, based on the event description, we can learn that the cap for fll was not screwed out and the tubing was not clamped by nursing staff, therefore blood leaked from cap for fll.Therefore, this event was not caused by the a.V.Fistula needle product.Information from the10 events for protective shield can be confirmed that they caused no serious injury to the patient and the user [21cfr803.3(c)&guidance for industry and food and drug administration staff(2.13)], and one blood leakage case of cap for fll was not related to a.V.Fistula needle product [ 21cfr803.20(c)(2) & guidance for industry and food and drug administration staff(2.16)].We confirm that these cases did not meet the serious injury event, therefore the 11 events are not reportable.This report is made out of an abundance of caution.5.Investigations and analyses for protective shield and cap for fll: 5.1 there was deformation for protective shield which may result in the difficulty use and protection failure.If protective shield has deformation problem, it can be discovered in time by visual during use, however, based on the event description, there was not deformation problem feedback provided by health professionals.We have conducted a full investigation from the production process records, final inspection records and retention samples, and no deformation problem was found.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 professionals needed time to adapt to the new one in clinical use, the 10 events we can confirm that the code 4396 dialysis center complained 9 times, code100449 dialysis center complained one time.Distributor said that 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 4396 and 100449 dialysis centers, and found no further complaint in these two centers.Therefore, the use problem for protective shield is mainly related to the adaptability of clinical use.5.2 referring to event information and requirements of ifu, it is confirmed that blood leakage from cap for fll was not related to a.V.Fistula needle product.6.Conclusion: 6.1 after assessing the events, we confirmed that 10 cases about protective shield were not serious injury events and blood leakage from cap for fll was not related to product, therefore, these cases are not reportable.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 the requests, and submitted the investigation results to the distributor, and they had no more comments to 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 use problem of protective shield is related to the adaptability about the health professional used new product.

Event Description

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).

• 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: 18175834
• MDR Text Key: 328623919
• Report Number: 3013217742-2023-00002
• Device Sequence Number: 1
• Product Code: FIE
• UDI-Device Identifier: 06948082700590
• UDI-Public: 06948082700590
• Combination Product (y/n): N
• PMA/PMN Number: K163025
• Number of Events Reported: 11
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: BAIN-A.V.F-001SG
• Device Lot Number: 201902011752
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2019
• 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