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

Model Number P180030; 180060CT

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

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

Event Type  malfunction  

Event Description

Customer reported the 30 cc and 60 cc syringes cannot be opened aseptically.The paper is tearing and is a problem for opening on a sterile field, releasing fibers from the paper.T was every single one of the 30 and 60 that did this.

• 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: 18496078
• MDR Text Key: 333101396
• Report Number: 3014312726-2024-00117
• 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: P180030; 180060CT
• Device Lot Number: 04006037; 04202010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1