MAUDE Adverse Event Report: SHINA MED CORPORATION SURE COMFORT; INSULIN SYRINGE

Model Number	22-9010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A cap was not on the syringe.The cap was inside the poly bag.Pt was stuck by the needle which was protruding from the poly bag.

• Brand Name: SURE COMFORT
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): SHINA MED CORPORATION; 455-30, bogaewonsam-ro; bogae-myeon kr-41; anseong-si, anseong-si gyeonggido 17509 ; KS 17509
• MDR Report Key: 18399205
• Report Number: 1000138447-2023-00009
• Device Sequence Number: 16819134
• Product Code: FMF
• UDI-Device Identifier: 00786227901053
• UDI-Public: 00786227901053
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/27/2023
• Report Date (Section F): 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 22-9010
• Device Lot Number: 230536AS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/17/2023
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 12/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male