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	05/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was given the sq heparin injection and safety needle would not function.Nurse tried to active the safety mechanism 3 times without success.

• 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: 8707109
• Report Number: 8707109
• Device Sequence Number: 11280958
• 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): 05/29/2019
• Report Date (Section F): 05/29/2019

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: K111A
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95
• Date Report Sent to FDA: 05/29/2019