MAUDE Adverse Event Report: ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD TKMD SAFETY NEEDLE; SYRINGE, ANTISTICK

Model Number	SKU: N-2315
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
[tkmd safety needle] use for covid-19 under emergency use authorization (eua): needle bends considerably when inserting into the safety device and can snap before clicking.More needle sticks have occurred using these needles than ever previously in our organization so we have great cause for concern and would like the issue to be studied further.Fda safety report id# (b)(4).

• Brand Name: TKMD SAFETY NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD; tianchang city, anhui ; CH
• MDR Report Key: 12007979
• Report Number: MW5101893
• Device Sequence Number: 1374873
• Product Code: MEG
• UDI-Device Identifier: 06934841570047
• UDI-Public: (01)06934841570047
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: SKU: N-2315
• Device Catalogue Number: TKSN-008
• Device Lot Number: 20201201
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1