MAUDE Adverse Event Report: ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. TKMD SAFETY NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	TKSN008
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, we determine that the reason for the failure of the safety sheath and the exposure of the needle is that the maintenance cycle of the safety sheath injection molding machine mold is too long, which leads to untimely mold maintenance and ultimately increases the defect rate of injection molded parts.
Event or Problem Description
Tkmd safety needle 23g 1in - safety failed 5 times in a single day with appropriate use by provider, leaving used needle exposed.Pt code: 4582.Device code: 1384.Ref reports: mw5177679, mw5177680, mw5177682, mw5177683.

• Brand Name: TKMD SAFETY NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.; no 228, weiyi road; economic development zone; tianchang, anhui 23930 0; CH 239300
• Manufacturer (Section G): ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.; no 228, weiyi road; economic development zone; tianchang, anhui 23930 0; CH 239300
• Manufacturer Contact: catherine guan ; no 228, weiyi road; economic development zone; tianchang, anhui 23930-0 ; CH 239300
• MDR Report Key: 23653034
• Report Number: 3007590959-2025-00000
• Device Sequence Number: 4824573
• Product Code: FMI
• UDI-Device Identifier: 06934841570030
• UDI-Public: 06934841570030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K191644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2026
• Device Model Number: TKSN008
• Device Catalogue Number: N2310
• Device Lot Number: 20210715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2021
• 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