MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. EASYPOINT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	82011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse practitioner administered vaccine and noticed that the needle did not retract.

• Brand Name: EASYPOINT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 9797797
• Report Number: 9797797
• Device Sequence Number: 2891026
• Product Code: FMI
• UDI-Device Identifier: 00613703820105
• UDI-Public: (01)00613703820105
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/11/2020
• Report Date (Section F): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82011
• Device Catalogue Number: 82011
• Device Lot Number: K180904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/11/2020