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

Catalog Number 10301

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

While administering subcutaneous heparin injection, the rn withdrew syringe, but needle stayed in patient.I removed needle and put in cap and taped over top to secure.No harm to patient.Nurse manager advised.Id numbers on container (catalog number 10301).Bar code #1370310300.

• Brand Name: VANISHPOINT SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo lane; little elm, TX 75068
• MDR Report Key: 4683328
• MDR Text Key: 5640742
• Report Number: 4683328
• 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
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 10301
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2015
• Patient Sequence Number: 1