MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-07 for INJECTION NEEDLE IN12-225232302 manufactured by Micro-tech(nanjing) Co.,ltd.
[187039635]
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.
Patient Sequence No: 1, Text Type: N, H10
[187039636]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004837686-2020-00001 |
| MDR Report Key | 9561849 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-05-24 |
| Date Mfgr Received | 2019-06-14 |
| Device Manufacturer Date | 2019-03-18 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BECKY LI |
| Manufacturer Street | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU |
| Manufacturer City | NANJING, JIANGSU 210032 |
| Manufacturer Country | CH |
| Manufacturer Postal | 210032 |
| Manufacturer G1 | MICRO-TECH(NANJING) CO.,LTD |
| Manufacturer Street | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU |
| Manufacturer City | NANJING, JIANGSU 210032 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 210032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INJECTION NEEDLE |
| Generic Name | INJECTION NEEDLE |
| Product Code | FBK |
| Date Received | 2020-01-07 |
| Catalog Number | IN12-225232302 |
| Lot Number | ME190318323 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO-TECH(NANJING) CO.,LTD |
| Manufacturer Address | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU NANJING, JIANGSU 210032 CH 210032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-07 |