MAUDE Adverse Event Report: WUXI YUSHOU MEDICAL APPLIANCES CO., LTD SAFETY HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number	W2106079
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Dirty needle stick.Rn had just finished an im(intramuscular) vaccine injection and was activating the safety on the needle.The needle did not slide into the safety and instead curled up poking the palm of the rn's hand.

• Brand Name: SAFETY HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): WUXI YUSHOU MEDICAL APPLIANCES CO., LTD
• MDR Report Key: 18302760
• Report Number: MW5149074
• Device Sequence Number: 6037353
• 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
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Lot Number: W2106079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White