MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M LUER LOCK SYRINGE

Model Number P180060T

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

Customer reported, they found a blue particle in the syringe.

• Brand Name: SOL-M LUER LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s wacker dr, suite 4100; chicago IL 60604
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC; 311 s wacker dr, suite 4100; chicago
• Manufacturer Contact: jarryd franklin
• MDR Report Key: 18496088
• MDR Text Key: 333093488
• Report Number: 3014312726-2024-00111
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: P180060T
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1