MAUDE Adverse Event Report: DUOPROSS MEDITECH (KUNSHAN) CO., LTD. DPS HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	REF: 100800000066
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pfizer use for covid-19 under emergency use authorization (eua): while being vaccinated, the needle stayed in the patient's arm once the syringe was pulled away.This equipment malfunction resulted in a nurse being poked by the contaminated needle.Fda safety report id# (b)(4).

• Brand Name: DPS HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): DUOPROSS MEDITECH (KUNSHAN) CO., LTD.
• MDR Report Key: 13236138
• Report Number: MW5106579
• Device Sequence Number: 11870111
• Product Code: FMI
• UDI-Device Identifier: 06971352289020
• UDI-Public: (01)06971352289020
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/08/2022
• 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: 06/11/2026
• Device Model Number: REF: 100800000066
• Device Lot Number: W2106085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic