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

Model Number	9760W631
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Staff were placing the needle on the syringe to administer the vaccine to the patient and the safety mechanism of the needle came off.No needle stick occurred.
Additional Manufacturer Narrative
The problem of mw5113021 has been communicated with the customer by email.After receiving the pictures, it was analyzed that it should be the misactivation caused by improper operation of medical staff (the activation failure caused by not operating correctly according to the instructions).After checking the appearance and structure of the retained samples of the same batch, activating the safety jacket according to the product instructions will not result in activation failure.In addition, our company has not received any other complaints regarding the failure or activation of safety jackets for the safety hypodermic needles exported and sold to the us and eu from 2020 to date.
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.
Event or Problem Description
Staff were placing the needle on the syringe to administer the vaccine to the patient and the safety mechanism of the needle came off.No needle stick occurred.
Event or Problem Description
Staff were placing the needle on the syringe to administer the vaccine to the patient and the safety mechanism of the needle came off.No needle stick occurred.
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.

• 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: 15850418
• Report Number: 3012116434-2022-00002
• Device Sequence Number: 14716035
• 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: 2
• 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