MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE¿ LUER LOCK SAFETY SYRINGE; SYRINGE, ANTISTICK

Model Number 120007IM

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

Icu rns were trying to transfer blood from syringe to specimen tube.The needle pulled inside the syringe and blood splashed everywhere.

• Brand Name: SOL-CARE¿ LUER LOCK SAFETY SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 315 shawnee north dr. suite 100; suwanee GA 30024
• MDR Report Key: 15601931
• MDR Text Key: 301736501
• Report Number: 15601931
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 120007IM
• Device Catalogue Number: 1200071M
• Device Lot Number: 04102046
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1