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

Model Number	82091
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Rn went to engage safety mechanism of intramuscular needle and the entire intramuscular needle top fell apart into many 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: 18571315
• Report Number: 18571315
• Device Sequence Number: 7140366
• 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): 10/04/2023
• Report Date (Section F): 10/04/2023

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: 82091
• Device Catalogue Number: 82091
• Device Lot Number: K210714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• 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
• Patient Sex: Female
• Patient Weight: 86 KG
• Date Report Sent to FDA: 10/04/2023