MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES VANISH POINT; VANISH POINT INSULIN SYRINGE

Model Number 15221

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2015

Event Type  malfunction  

Event Description

Insulin syringe failed to retract after use.This occurred with two syringes in this lot.No injury to patient or staff.

• Brand Name: VANISH POINT
• Type of Device: VANISH POINT INSULIN SYRINGE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES; 511 lobo lane; little elm TX 75068
• MDR Report Key: 5148685
• MDR Text Key: 28308420
• Report Number: MW5056959
• Device Sequence Number: 2
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Service Personnel
• Report Date: 10/06/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 15221
• Device Lot Number: M141101
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1