MAUDE Adverse Event Report: SMITH MEDICAL ASD, INC SMITH MEDICAL HYPODERMIC NEEDLE PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	4290
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Blue needle base detached from orange safety mechanism and remained in patient's arm after vaccine administration.Fda safety report id # (b)(4).

• Brand Name: SMITH MEDICAL HYPODERMIC NEEDLE PRO NEEDLE WITH NEEDLE PROTECTION DEVICE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITH MEDICAL ASD, INC
• MDR Report Key: 11831820
• Report Number: MW5101379
• Device Sequence Number: 3793073
• Product Code: FMI
• UDI-Device Identifier: 20351688046823
• UDI-Public: 20351688046823
• Initial Reporter State: SC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: 04/04/2024
• Device Model Number: 4290
• Device Lot Number: 3807640
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 59