MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M CATHETER TIP SYRINGE

Model Number 180060CT

Device Problems Contamination (1120); Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

Customer reported, we have a problem with the saguenay surgical priority sol-m syringes.The envelope of the syringes tear.Therefore, contaminates the syringe.And we cannot put them on our drapes, and we contaminate the drapes.Packaging tears causing product to become unsterile.

• Brand Name: SOL-M CATHETER TIP 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: 18498038
• MDR Text Key: 333197792
• Report Number: 3014312726-2024-00116
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 180060CT
• Device Lot Number: 04105105
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1