MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT INSULIN SYRINGE U-100

Model Number U-100

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 05/07/2016

Event Type  Injury  

Event Description

Insulin syringe retractable point did not function.The syringe we use had malfunctioned several times for me (this is at least the third time) since we have started using them.Vanishpoint insulin syringe nafdac #03-0623, ref (b)(4).

• Brand Name: VANISHPOINT INSULIN SYRINGE U-100
• Type of Device: VANISHPOINT INSULIN SYRINGE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; little elm TX 75068
• MDR Report Key: 5646264
• MDR Text Key: 44985031
• Report Number: MW5062186
• 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: 05/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U-100
• Device Catalogue Number: 15221
• Device Lot Number: 15221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR