MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HTL/DROPLET INSULIN SYRINGE

Model Number 6001

Device Problem Dull, Blunt (2407)

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

Event Type  malfunction  

Event Description

Customer reported, she has been experiencing problems with multiple dull needles.She has been using our products for over a year, and she has not had any problems like this.She says, she received another box from the pharmacy with same lot #, and that box is good.No dull needles observed, so far.

• Brand Name: HTL/DROPLET 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: 18496091
• MDR Text Key: 333093838
• Report Number: 3014312726-2024-00164
• 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: 01/11/2024

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: 6001
• Device Lot Number: 02206035
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1