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

Catalog Number	IN12-255232302
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The products released for distribution were found to have met all specifications prior to shipment and found no abnormalities.2.Based on customer feedback, we have conducted an investigation from ifu, and the specific investigation information is as follows: the instructions describe preoperative examination work in step 7-9 of the preparation work.Step 7.Operate the handle and verify needle advancement.Do not use if the needle doesn't deploy.Step 8.Release the lock on the handle to retract the needle into the outer sheath.Do not use if the needle doesn't retract into the sheath.Step 9.Secure the syringe onto the luer port on the handle.The ifu includes the operation of checking tip of the needle.We suggest that users check the product according to the instructions before operation to avoid similar problems from occurring.Note: this mdr report was sent to fda via esg on april 2, 2024.However, on september 23, 2024, we checked the fda maude database and did not find any report records.After confirmation, it was found that this report was not recorded in the system due to the mfr report number being written as 3004837686-2024-00003, which is the same as the report number of another mdr report od cold snare.Therefore, this mdr report of injection needle is resubmitted.
Event or Problem Description
Micro-tech received a mdr notification from fda.Mdr report #: mw5152104.It was reported that injection needle has a clear tip cover that is the same color as the tubing and easily fits through the scope channel.The user inadvertently forgot to remove the tip cover and the tip came off in the patients colon and had to be retrieved.There was no injury to patient due to this error.Recommend tip cover color and size be revised to avoid future incident.

• Brand Name: INJECTION NEEDLE
• Common Device Name: 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: 20277425
• Report Number: 3004837686-2024-00005
• Device Sequence Number: 18116992
• Product Code: FBK
• UDI-Device Identifier: 06932503533249
• UDI-Public: (01)06932503533249(17)260116(10)M230117321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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 Expiration Date: 01/16/2026
• Device Catalogue Number: IN12-255232302
• Device Lot Number: M230117321
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown