MAUDE Adverse Event Report: ANHUI HONGYU WUZHOU MANUFACTURER CO.,LTD. DPS SAFETY NEEDLE; HYPODERMIC SAFETY NEEDLE

Model Number	9760W631
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mw5113018 problem has been communicated with the guest by email, the guest and the report reporter failed to provide more information than the report, combined with the report of mw5113021 problem picture analysis should be caused by improper operation of medical staff stabbing (not according to the correct operation of the instructions lead to activation failure, stabbed), after checking the appearance and structure of the retained samples of the same batch of products, activating the safety sheath according to the product instructions will not cause activation failure.In addition, the safety hypodermic needles exported and sold by our company to the united states and the european union from 2020 to now have not received relevant complaints about the safety sheath not activated or activation failure or being stabbed.
Event or Problem Description
Needle was sticking out of safety sheath after mechanism was engaged.This caused a staff needle stick after vaccine administration.
Additional Manufacturer Narrative
The corrections are as follows: 1.In part d2, the product code is changed from fmi to meg; 2.In part h1, the summary report was cancelled.
Event or Problem Description
Needle was sticking out of safety sheath after mechanism was engaged.This caused a staff needle stick after vaccine administration.
Event or Problem Description
Needle was sticking out of safety sheath after mechanism was engaged.This caused a staff needle stick after vaccine administration.
Additional Manufacturer Narrative
The corrections are as follows: in section d2, change the product code of the last supplementary report from meg to fmi; in part h1, the summary report was cancelled.

• Brand Name: DPS SAFETY NEEDLE
• Common Device Name: HYPODERMIC SAFETY NEEDLE
• Manufacturer (Section D): ANHUI HONGYU WUZHOU MANUFACTURER CO.,LTD.; no.2 guanyin road; economic development zone; taihu county,anqing, anhui 24640 0; CH 246400
• Manufacturer (Section G): ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.; no.2 guanyin road,; economic development zone,; taihu county,anqing, anhui 24640 0; CH 246400
• Manufacturer Contact: sales manager zhang ; no.2 guanyin road,; economic development zone,; taihu county,anqing, anhui 24640-0 ; CH 246400
• MDR Report Key: 15850413
• Report Number: 3012116434-2022-00001
• Device Sequence Number: 5202159
• Product Code: FMI
• UDI-Device Identifier: 16958697602315
• UDI-Public: (01)16958697602315(17)260324(11)210325(10)20210325
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211555
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2023
• 2 Devices were Involved in the Event: 1 2

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: 03/24/2026
• Device Model Number: 9760W631
• Device Lot Number: 20210325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2022
• Supplement Date Received by Manufacturer: 11/05/2022; 11/05/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 11/14/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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