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

Model Number	22-6510
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient using insulin syringe for ed injections.The needle broke at the interface between the cannula and syringe barrel during an injection, leaving the cannula inside his body.

• Brand Name: SURE COMFORT
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): SHINA MED CORPORATION; 455-30, bogaewonsam-ro bogae-m; anseong-si, gyeonggido, 17509 ; KS 17509
• MDR Report Key: 15890043
• Report Number: 1000138447-2022-00002
• Device Sequence Number: 15151890
• Product Code: FMF
• UDI-Device Identifier: 00786227651057
• UDI-Public: 00786227651057
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/01/2022
• Report Date (Section F): 08/04/2022

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: 22-6510
• Device Catalogue Number: 22-6510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2018
• Event Location: Home
• Date Report to Manufacturer: 08/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2022
• 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: 55 YR
• Patient Sex: Male