MAUDE Adverse Event Report: HENRY SCHEIN, INC. SAFETY NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	9007651
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Phlebotomist was collecting blood sample when needle separated from the base and safety device.The needle remained in the patient's arm and had to be removed by hand, and safety device could not be engaged.Fda safety report id# (b)(4).

• Brand Name: SAFETY NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HENRY SCHEIN, INC.; 135 duryea road; e-355; melville NY 11747
• MDR Report Key: 13417134
• Report Number: MW5107097
• Device Sequence Number: 12208869
• Product Code: FMI
• UDI-Device Identifier: 00304040017258
• UDI-Public: (01)00304040017258(17)260325(10)
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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: 03/25/2026
• Device Model Number: 9007651
• Device Catalogue Number: 900-7651
• Device Lot Number: 02102018
• 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: 01/31/2022
• 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: Required Intervention
• Patient Sex: Unknown