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

Catalog Number IN12-255232302

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

On 2020/12/21, micro-tech endoscopy quality assurance specialist connie space had an investigation about this event.This event was reported by (b)(6).She said that she was not in the room when the malfunction happened but after speaking with the nurse in the room, (b)(6), she stated the leak was at the luer lock.It was a secure fit but the ink leaked out.The malfunctioning equipment was not saved and could not be evaluated.Micro-tech will try to get more information from the customer to analyze this complaint.The complaint investigation is still ongoing.A follow-up report will be filed following the completion of the complaint investigation.

Event Description

On 2020/12/15, micro-tech complaint engineer had a company-related adverse event search on fda maude website.There was a voluntary event report regarding 2 micro-tech injection needles which had malfunctions in the procedure.Mdr report number: mw5097220.Event description: the event that happened with both devices was there was a hole in the catheter which allowed the spot ink to spill out and not be injected in the mucosa.No harm was caused.

Manufacturer Narrative

1.The customer complained that there was leakage of the injection needle, and the number of defective products was 2pcs.Due to the lack of sample and picture information, we were unable to conduct physical analysis, so we conducted internal investigation and inferential analysis.2.Stock, production records, infusion handle incoming material confirmation.2.1 stock: the injection needles of batch m190826326 have been all shipped out.There is no injection needle left in mt inventory.2.2 production records: review the dhr of this batch, and the production record is normal.The products have passed various inspections, including appearance check and air leakage test before leaving the factory.2.3 raw material of infusion handle: according to dhr information, the batch number of infusion handle used for this batch of injection needle is 20190816j02-i016.Further query the iqc entry record of this batch of handle, the total input number of infusion handle is (b)(4) pcs, and the iqc record is normal.Appearance of infusion handle and the dimension of lure connector meets requirement.And this entire batch has been used for the production of injection needle, and the remaining quantity of raw materials is 0.Summary: according to the above investigation of raw material storage records, production records and finished product inventory, no abnormality was found in the inspection before delivery.3.From year 2019 to year 2020, (b)(4) needles were sold in total.This is the first time that we received customer complaints about handle leakage.The defective ratio is about 2.15*10-6.There is no historical analysis result for reference.Due to the low probability of occurrence, we think it is accidental and will continue to pay attention to it.Conclusion: after the above confirmation of raw materials, production records and historical customer complaints, we cannot find the actual causes of the adverse events.Therefore, we will continue to pay attention to similar defects in the market in order to collect samples for analysis.This issue will continue to be monitored through the complaint system to assure patient safety.

• 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
• MDR Report Key: 11064068
• MDR Text Key: 252299686
• Report Number: 3004837686-2020-00007
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

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
• Device Operator: No Information
• Device Expiration Date: 08/25/2022
• Device Catalogue Number: IN12-255232302
• Device Lot Number: M190826326
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1