MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES INC. VANISHPOINT SYRINGES 1ML; SYRINGE, ANTISTICK

Model Number U-100

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2019

Event Type  malfunction  

Event Description

Ten vanishpoint insulin syringes were opened and holes were noted in the syringes.Appeared to look like burned holes.Fda safety report id# (b)(4).

• Brand Name: VANISHPOINT SYRINGES 1ML
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES INC.
• MDR Report Key: 8731049
• MDR Text Key: 149252889
• Report Number: MW5087585
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• 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: 06/20/2019
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U-100
• Device Lot Number: F356A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1