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

Device Problems Defective Component (2292); Structural Problem (2506)

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

Event Date 12/21/2022

Event Type  malfunction  

Event Description

While preparing to administer a covid vaccine to veteran, i noticed that the vantage point needle was shorter than usual.After examining, i found that need was slightly retracted into barrel and was defective.The needle was not used.

• Brand Name: VANISHPOINT SYRINGES
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC; little elm TX 75068
• MDR Report Key: 16502386
• MDR Text Key: 310957440
• Report Number: MW5115513
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Hispanic
• Patient Race: White