MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGY INC. VANISHPOINT INSULIN SYRINGE

Model Number 10211

Device Problem Fail-Safe Design Failure (1222)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2018

Event Type  malfunction  

Event Description

Brew up and integrated insulin into patient's arm.Depressed the retracting button but the needle was still exposed.

• Brand Name: VANISHPOINT INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGY INC. ; little elm TX 75068
• MDR Report Key: 7464097
• MDR Text Key: 106791552
• Report Number: MW5076752
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: 10211
• Device Catalogue Number: 10211
• Device Lot Number: F171207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1