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

Catalog Number 10161

Device Problems Defective Component (2292); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2021

Event Type  Injury  

Event Description

Vanish point syringe, supplied under eua in the pfizer covid vaccine kits with defective needle; bent needle.

• Brand Name: VANISH POINT SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC. ; little elm TX 75068
• MDR Report Key: 11628083
• MDR Text Key: 244426354
• Report Number: MW5100587
• Device Sequence Number: 1
• Product Code: MEG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2021

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: Health Professional
• Device Catalogue Number: 10161
• Device Lot Number: G201010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention