MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES VANISHPOINT SYRINGE

Model Number 10301

Device Problems Fail-Safe Design Failure (1222); Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/26/2017

Event Type  malfunction  

Event Description

Employee sustained a needle stick as a result of the needle failing to retract.

• Brand Name: VANISHPOINT SYRINGE
• Type of Device: VANISHPOINT SYRINGE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES; little elm TX 75068
• MDR Report Key: 6680605
• MDR Text Key: 78985113
• Report Number: MW5070742
• 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: Physician
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10301
• Device Catalogue Number: 10301
• Device Lot Number: A16073
• Was Device Available for Evaluation?: No
• 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