MAUDE Adverse Event Report: WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD. DPS; 25G X 1" SAFETY NEEDLE WITHOUT SYRINGE

Model Number	25G X 1"
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse who administered the covid-19 vaccine reported that she faced issues while using the 25g, 1" dps safety needle.The needle point was not sharp; it was blunt.The common issue occurred when vaccinating a patient.The needle penetration required extra force, and feedback was received from the patient that the experience was painful.
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.The device manufacturer printed on the product packaging is identified in section d, and the device distributor printed on the packaging is duopross meditech corporation (refer to duopross.Com for additional information).We have notified asprsnsopscell@cdc.Gov and barda-rqaproductacceptance@hhs.Gov for awareness.

• Brand Name: DPS
• Common Device Name: 25G X 1" SAFETY NEEDLE WITHOUT SYRINGE
• Manufacturer (Section D): WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.; no. 215 xigang road; dongbeitang town, xishan dist.; wuxi, jiangsu 21419 1; CH 214191
• 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: 16431846
• Report Number: 3017368639-2023-00001
• Device Sequence Number: 5297486
• Product Code: FMI
• UDI-Device Identifier: 06971352289020
• UDI-Public: 06971352289020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130212
• 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
• Type of Report: Initial
• Report Date (Section B): 02/13/2023

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: 12/24/2025
• Device Model Number: 25G X 1"
• Device Catalogue Number: 100800000066
• Device Lot Number: 2012057
• 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: 01/25/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/25/2020
• 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