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

Catalog Number 10271

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/01/2014

Event Type  No Answer Provided  

Event Description

After drawing up the patient's insulin, the nurse recapped the needle prior to the injection and the needle came out of the cap.

• Brand Name: VANISHPOINT
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo lane; little elm TX 75068
• MDR Report Key: 3933992
• MDR Text Key: 4573280
• Report Number: 3933992
• 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: 06/10/2014

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?: *
• Device Operator: Nurse
• Device Catalogue Number: 10271
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2014
• Patient Sequence Number: 1