MAUDE Adverse Event Report: ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. TKMD; 23G X1 1/2" HYPODERMIC SAFETY NEEDLE

Model Number	N-2315
Medical Device Problem Codes	Retraction Problem (1536); Unintended Movement (3026)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant reported multiple needlestick events where the safety shields on the blue 23gx1.5" needle either becomes off center and does not lock or cover the needle.Additionally, the needle shield can be pushed back open even after it has been locked.
Additional Manufacturer Narrative
(b)(4) is the assembler of convenience kits that could contain the device from the manufacturer identified in section d.The item ref # and lot # reported and identified in section d have been confirmed as having been used in the assembly of convenience kits supplied by (b)(4).We have notified (b)(4) for awareness.

• Brand Name: TKMD
• Common Device Name: 23G X1 1/2" HYPODERMIC SAFETY NEEDLE
• Manufacturer (Section D): ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.; no 228, weiyi road; economic development zone; tianchang city, anhui 23930 0; CH 239300
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: akash gami ; 9954 mayland drive; richmond, VA 23233 ; 7792406767
• MDR Report Key: 17455196
• Report Number: 3017368639-2023-00008
• Device Sequence Number: 20655018
• Product Code: FMI
• UDI-Device Identifier: 06934841570047
• UDI-Public: 06934841570047
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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: 07/10/2026
• Device Model Number: N-2315
• Device Catalogue Number: TKSN-008
• Device Lot Number: 20210710
• 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: 07/05/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2021
• 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