MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. U-100 30 G 5/16" 1 ML VANISHPOINT INSULIN SYRINGE; SYRINGE, ANTISTICK

Model Number K38585

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2023

Event Type  malfunction  

Event Description

Registered nurse (rn) was drawing up insulin to administer.Insulin began entering the body of the syringe past the plunger.Rn noticed prior to going to patient room.

• Brand Name: U-100 30 G 5/16" 1 ML VANISHPOINT INSULIN SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 19003222
• MDR Text Key: 338898036
• Report Number: 19003222
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K38585
• Device Catalogue Number: K38585
• Device Lot Number: F220505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1