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

Catalog Number	22-6505
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Needle bond failure.The needle is pushed inside the syringe during use.

• 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: 19323321
• Report Number: 1000138447-2024-00004
• Device Sequence Number: 18036621
• Product Code: FMF
• UDI-Device Identifier: 00786227650555
• UDI-Public: 00786227650555
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/15/2024
• Report Date (Section F): 04/19/2024

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: Lay User/Patient
• Device Catalogue Number: 22-6505
• Device Lot Number: 230632AS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/16/2024
• Date Report to Manufacturer: 04/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• 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 Sex: Unknown