MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE INSULIN SYRINGE

Model Number 100017IM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

The customer reported the nurse was going to administer insulin to the patient in the abdomen and after administering, removed the syringe and did not see the needle.Needle broke and stayed inside the patient.Existence of needle was confirmed by xray.

• Brand Name: SOL-CARE 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: 18496081
• MDR Text Key: 332728943
• Report Number: 3014312726-2024-00115
• 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

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 100017IM
• Device Lot Number: 01103036
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1