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

Model Number	82091
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After administering flu vaccine, needle safety device activated by pressing orange button, needle shot into air and both hub and needle mechanism broke into pieces.Pieces were able to be recovered and no one was hurt or hit by any of the pieces.

• 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: 9314669
• Report Number: 9314669
• Device Sequence Number: 16295430
• Product Code: FMI
• UDI-Device Identifier: 00613703820907
• UDI-Public: (01)00613703820907
• 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): 10/16/2019
• Report Date (Section F): 10/16/2019

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 Model Number: 82091
• Device Catalogue Number: 82091
• Device Lot Number: K190204
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2019
• 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: 10/16/2019