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

Model Number	85291
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presented to the infusion center for vidaza injections.Patient reports significant pain/discomfort with our current needle system.Easypoint needle: 25g x 5/8".Retractable technologies inc lot: k211201.Patient requests that nursing remove the needle and then disengage to decrease the pain.

• 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: 17134036
• Report Number: 17134036
• Device Sequence Number: 7434289
• Product Code: FMI
• UDI-Device Identifier: 00613703852908
• UDI-Public: (01)00613703852908
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2023
• Report Date (Section F): 06/06/2023

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: 85291
• Device Catalogue Number: 85291
• Device Lot Number: K211201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 06/06/2023