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

Lot Number	20201101
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A hair was found in a sterile singly use safety needle package.Product description: size 21 g x 1 1/2".(b)(4).

• Brand Name: TKMD SAFETY NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ANHUI TIANKANG MEDICAL TECHNOLOGY CO. LTD; south of tiankang road and; west of jingsi road,xicheng district ; tianchang 23930 0; CH 239300
• MDR Report Key: 11588321
• Report Number: MW5100351
• Device Sequence Number: 14330350
• Product Code: FMI
• UDI-Device Identifier: 06934841570054
• UDI-Public: 0 6934841 57005 4
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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 Lot Number: 20201101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1