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

Model Number 85291

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 05/24/2023

Event Type  malfunction  

Event Description

Patient presented to the infusion center for velcade treatment.Patient reports more pain and discomfort with the new needle system in place.Easypoint needle, retractable technologies inc, lot: k211201.

• 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: 17134121
• MDR Text Key: 317220872
• Report Number: 17134121
• 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: 06/02/2023,05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 85291
• Device Catalogue Number: 85291
• Device Lot Number: K211201
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1