MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISH POINT 3ML SYRINGE 22G X1"; SYRINGE, ANTISTICK

Lot Number A211016

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  malfunction  

Event Description

Patient was to receive an im injection and the syringe malfunctioned while medication was being administered.The safety mechanism did not work, and the rubber gasket popped out of the back of the syringe.The medication to be administered spilled out of the back of the syringe causing the patient to not receive the medication.

• Brand Name: VANISH POINT 3ML SYRINGE 22G X1"
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 18885268
• MDR Text Key: 337426892
• Report Number: 18885268
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: A211016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male