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

Model Number 82091

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Difficult to Open or Close (2921)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/15/2021

Event Type  malfunction  

Event Description

Could not flip up needle protection cap, rn accidentally stuck in hand trying to dispose of needle.

• Brand Name: EASYPOINT
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 11640669
• MDR Text Key: 244629738
• Report Number: 11640669
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 82091
• Device Catalogue Number: 82091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1