MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISH POINT 3 ML SYRINGE 25 GAUGE X 1 INCH; SYRINGE, ANTISTICK

Catalog Number REF 10391

Device Problems Collapse (1099); Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

While attempting to inject an im medication into the dorsogluteal muscle, the plunger "collapsed" to the end of the syringe, while spraying a good amount of the medication on the nurse which came from the tip of the syringe where the orange top is, and noted there was still medication in the syringe and patient stated he didn't feel anything go in.Fda safety report id# (b)(4).

• Brand Name: VANISH POINT 3 ML SYRINGE 25 GAUGE X 1 INCH
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.
• MDR Report Key: 14187494
• MDR Text Key: 289957516
• Report Number: MW5109261
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF 10391
• Device Lot Number: A949A
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American