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

Model Number 15271

Device Problems Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/05/2022

Event Type  malfunction  

Event Description

Rn drew up lantus insulin with 0.5ml u-100 insulin syringe.Upon placing the cap on the need after drawing it up, the needle poked through the side of the cap and poked the nurse slightly.Another insulin syringe obtained to redraw insulin and upon removing the cap, the needle noted to be bent and was unable to be used.Manufacturer response for insulin syringe, vanishpoint 0.5ml u-100 insulin syringe (per site reporter).They sent an rga for us to return the product for investigation.

• Brand Name: VANISHPOINT
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 14851714
• MDR Text Key: 294939566
• Report Number: 14851714
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15271
• Device Catalogue Number: 15271
• Device Lot Number: M211104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1