MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE 1ML INSULIN SYRINGE W/FIXED NEEDLE

Model Number	100017IM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Skin Tears (2516)
Type of Reportable Event	Malfunction
Event or Problem 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.No additional information provided.

• Brand Name: SOL-CARE 1ML INSULIN SYRINGE W/FIXED NEEDLE
• Common Device Name: INSULIN SYRINGE W/FIXED NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker drive; chicago IL 60604
• MDR Report Key: 17074696
• Report Number: 3014312726-2023-00004
• Device Sequence Number: 15163949
• Product Code: FMI
• UDI-Device Identifier: 00818392014907
• UDI-Public: 00818392014907
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100017IM
• Device Catalogue Number: 100017IM
• Device Lot Number: 01103036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female