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

Model Number 15221

Device Problem Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/29/2019

Event Type  malfunction  

Event Description

Rn taking the syringe out of the package when she was stuck by a needle.The insulin syringe had a needle sticking out of the base of syringe to the side instead of in the center from the hub.

• Brand Name: VANISHPOINT
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 8619353
• MDR Text Key: 145369999
• Report Number: 8619353
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15221
• Device Catalogue Number: 15221
• Device Lot Number: M180702
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other