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

Model Number P180020

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

"customer reported: we had an incident today with the following 20cc syringe that cracked during use while pushing/expelling blood into a waste container.The syringe split/cracked and the blood shot out the side of the syringe thru the crack." see attachment initial email from customer.".

• Brand Name: SOL-M LUER LOCK SYRINGE
• Type of Device: SYRIN
• 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: 18476038
• MDR Text Key: 332446211
• Report Number: 3014312726-2024-00040
• 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: P180020
• Device Lot Number: 04105086
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1