MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC TECHLITE INSULIN SYRINGE

Model Number 260305

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

Customer reported, that they saw a crack on the side of the syringe.Where he can run his finger nail through.

• Brand Name: TECHLITE INSULIN 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 IL
• Manufacturer Contact: jarryd franklin
• MDR Report Key: 18498131
• MDR Text Key: 333197396
• Report Number: 3014312726-2024-00123
• 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: 260305
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1