MAUDE Adverse Event Report: CHENGDU XINJIN SHIFENG MEDICAL SHIFENG; 25G SHIFENG SAFETY NEEDLE

Model Number	N-2510
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
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.Item ref # and lot # reported and identified have been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified (b)(6).
Event or Problem Description
Customer reported that the issue was with the shifeng product supplied in the kit, indicating that the safety doesn't always latch right away.It takes more pressure to get the safety to engage.Customer provided mfr# n-2510 and lot # 210307 as additional product identification information.

• Brand Name: SHIFENG
• Common Device Name: 25G SHIFENG SAFETY NEEDLE
• Manufacturer (Section D): CHENGDU XINJIN SHIFENG MEDICAL; no46, 7th group; wanjie villag; ozorków, xinping, chengdu, sichuan ; CH
• 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: 15781234
• Report Number: 3017368639-2022-00032
• Device Sequence Number: 20616397
• Product Code: FMI
• UDI-Device Identifier: G001N25100
• UDI-Public: G001N25100
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142765
• 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
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: 03/07/2026
• Device Model Number: N-2510
• Device Lot Number: 210307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/11/2022
• 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