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

Model Number 10311

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 11/08/2020

Event Type  malfunction  

Event Description

Nurse was giving medications and during administration the medication went behind the plunger and patient did not get all the medication.This is the 5th malfunction with this syringe.

• Brand Name: VANISHPOINT
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 10927242
• MDR Text Key: 218921715
• Report Number: 10927242
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00613703103109
• UDI-Public: (01)00613703103109
• 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: 11/09/2020

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 Model Number: 10311
• Device Catalogue Number: 10311
• Device Lot Number: A93BA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA