MAUDE Adverse Event Report: JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD. VESCO LUER LOCK SYRINGE 10 ML; SYRINGE, PISTON

Catalog Number VIV-620EO

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

Vesco medical 20 ml luer lock syringe had particles on the inside of the syringe, they did not move with the solution that was pulled up in the syringe.Upon close examination, the particles were discovered and the medication was discarded.The compounding of the medication was re-started, using a fresh syringe.Fda safety report id # (b)(4).

• Brand Name: VESCO LUER LOCK SYRINGE 10 ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD.
• MDR Report Key: 12590073
• MDR Text Key: 275877622
• Report Number: MW5104453
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VIV-620EO
• Device Lot Number: 20210503
• Was Device Available for Evaluation?: Yes
• 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