MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-GUARD TB SAFETY SYRINGE

Model Number 200034SG

Device Problem Dull, Blunt (2407)

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

Event Type  malfunction  

Event Description

Tried to give a client the moderna vaccine and the needle was having difficulty going into skin.Needle never did pierce skin rather only indented skin with no blood at all.Drew up another moderna vaccine with a different needle and gave this vaccine with no issues.Threw out other non functional needle in sharps and let leads know immediately.

• Brand Name: SOL-GUARD TB SAFETY 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: 18476045
• MDR Text Key: 332446224
• Report Number: 3014312726-2024-00039
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 200034SG
• Device Lot Number: 01106023
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1