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

Model Number	TKSN-006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that can 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 mckesson medical-surgical, inc.We have notified asprsnsopscell@cdc.Gov and barda-rqaproductacceptance@hhs.Gov for awareness.
Event or Problem Description
Customer reported that, on three separate occasions, tkmd needles failed to engage with the safety sheath after administration.The customer indicated that the safety feature broke off before the needle encased correctly, and the needle poked through the sheath.

• Brand Name: TKMD
• Common Device Name: TKMD SAFETY NEEDLE
• Manufacturer (Section D): ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.; no. 228, weiyi road; west development zone; tianchang, anhui province 23930 0; CH 239300
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 16156877
• Report Number: 3017368639-2022-00035
• Device Sequence Number: 2661576
• Product Code: FMI
• UDI-Device Identifier: 06934841570016
• UDI-Public: 06934841570016
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2023

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: 04/05/2026
• Device Model Number: TKSN-006
• Device Catalogue Number: N-2510
• Device Lot Number: 20210405
• 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: 12/14/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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