MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES INC. VANISHPOINT; SYRINGE, ANTISTICK

Catalog Number 10391

Device Problems Leak/Splash (1354); Output Problem (3005)

Patient Problem Anxiety (2328)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

Nurse injecting medication into patient's arm when popping noise heard, following by the needle retracting, leaving some of the medication in the barrel.Leakage also noted around the syringe.Device: vanishpoint 3ml 35ga 1" needle/syringe with retractable needle.Nurse had to draw up new dose of medication from pyxis, second shot given.This caused the patient anxiety "is the needle still in my arm?".The nurse had to access pyxis for another dose.Fda safety report id# (b)(4).

• Brand Name: VANISHPOINT
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES INC.; little elm TX 75068
• MDR Report Key: 13002029
• MDR Text Key: 282323240
• Report Number: MW5106013
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10391
• Device Lot Number: A938A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Race: American Indian Or Alaskan Native