MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES VANISHPOINT INSULIN SYRINGE

Model Number 15221

Device Problems Insufficient Flow or Under Infusion (2182); Inappropriate or Unexpected Reset (2959)

Patient Problem Underdose (2542)

Event Date 11/13/2015

Event Type  malfunction  

Event Description

The needle retracted by itself during insulin administration, and a substantial amount of the insulin was not injected from the syringe.

• Brand Name: VANISHPOINT INSULIN SYRINGE
• Type of Device: VANISHPOINT INSULIN SYRINGE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES; 511 lobo lane; little elm TX 75068
• MDR Report Key: 5256762
• MDR Text Key: 32375943
• Report Number: MW5058180
• Device Sequence Number: 1
• Product Code: MEG
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15221
• Device Lot Number: M140902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1