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

Catalog Number 10271

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Nurse sates that the needle on vanishpoint came through the orange cap prior to patient use.

• Brand Name: VANISHPOINT
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo lane; little elm TX 75068
• MDR Report Key: 4104812
• MDR Text Key: 21880685
• Report Number: 4104812
• Device Sequence Number: 1
• Product Code: MEG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 10271
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2014
• Patient Sequence Number: 1