MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD INJECTION NEEDLE

Catalog Number IN12-225232302

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint product analysis: appearance confirmation: comparing the defective products with qualified product, it is found that there are slight depressions of the clamping groove for the defective product.The handle cannot be locked.Cause investigation: 1.Raw material investigation: 1.1 we reviewed the incoming inspection records of handles for nearly one year and found no appearance problems similar to this complaint.1.2 because the needle length should be 100% checked during the production line, and the checking can only be carried out when the clamping teeth and clamping grooves are fully clamped.If the incoming material has a clamping groove depression, the needle cannot be maintained after extending, thus the length of the needle cannot be checked.Summary: based on the above analysis, it can be excluded that the handle raw materials are defective.2.Product assembly process investigation: checking injection needle assembly process, no continuous force applied to the groove surface, will not cause groove depression.It is clearly required in the process to check whether the groove is deformed before assembling at first step of shell installation, so eliminate the causes happened in assembling process.3.Inner packaging process investigation: before packaging, wipe the products one by one with dust-free cloth dipped in alcohol, and then wrap the product into an oval shape after each wiping, and put it into the inner packaging bag.This process will not press the clamping groove, so the packaging process can't possibly cause this defect.4.Circulation process investigation after packaging process: when circulation box superimposed placed, there is a probability that the injection needle in the lower box will be squeezed by the upper box if the products placed irregularly.It may squeeze at the point where the clamping groove is.For this risk, we conducted simulation verification to confirm the possibility of this defect.In order to simulate the worst situation, we full-filled the box with products to confirm the possibility of clamping groove deformation under maximum pressure.Put the product into the bottom of the box for squeeze, and ensuring that the squeeze force point is the surface of the clamping groove, and the pressure is vertical downward.Lasting 4h(normal circulation time should be 1~2h) result: we totally conduct 5 simulation verification, 5 products were squeezed, no handle failure found after the experiment.So the circulation process can be eliminated as the cause of this defect.By reviewing the history of customer complaints, from 2018 to may 2019, the sales volume of injection needles was 350878 pcs.Only one case of customer complaints caused by the depression of the clamping groove.The probability of the failure was 2.85*10-6.The probability was very low.Risk assessment: the needle handle does not work properly since it doesn't stop, and the medical staff needs to replace another product, which may result in a slight extension of the operation time, but will not cause harm to the patient.A complaint history review from january 2018 to may 2019 was conducted and found a total of one complaint for this lot number and failure mode.During this same time frame 350878 devices have been manufactured and shipped worldwide.The rate of failure would be 2.85*10-6, it was low.Combined with the severity and probability analysis of occurrence, the risk is within a reasonable and controllable range.General comments: after analyzing the returned customer complaint sample, we found the handle had a issue with the clamping groove.So, we did investigations on the causes which may lead to this failure, including the raw material of outer shell, product assembly process, inner packaging process, circulation process after packaging process.But we have not found the possible causes of the handle failure.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A complaint history review shows this failure mode has a very low probability of occurrence.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

It was reported that the ratchet in the handle didn't work properly, when the needle got out it was impossible to stop it.No problem for the patient.

• Brand Name: INJECTION NEEDLE
• Type of Device: INJECTION NEEDLE
• Manufacturer (Section D): MICRO-TECH(NANJING) CO.,LTD; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer (Section G): MICRO-TECH(NANJING) CO.,LTD; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer Contact: becky li ; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 9561849
• MDR Text Key: 187039635
• Report Number: 3004837686-2020-00001
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K150434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Catalogue Number: IN12-225232302
• Device Lot Number: ME190318323
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 73 YR