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	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause analysis result: the previously used insulin syringe 31g x 8mm(5/16in) x 1 ml complies with iso standards, and it was judged that there was no problem before use.The broken needle was used by the user for a purpose other than its intended use, and it is judged that it was caused by using a fine needle that was not suitable for the purpose.Root cause: 1.The 2019 manufacturing record, process inspection record, and product inspection record were reviewed, but there were no special issues.2.The 31g x 8mm(5/16in) x 1 ml needle import inspection report in 2019 was reviewed, but there were no special issues.3.In the import inspection, stiffness, resistance to breakage of needle was performed in accordance with iso 9626, and all conformed to iso standards.However, the stiffness varies a lot depending on the needle gauge and wall type (regular wall, thin wall, extra thin wall, ultra-thin wall).In other words, if there is a lot of load during injection, the use of thick gauges and regular walls is encouraged.However, the 31g cannot withstand a lot of load due to its fine needle.4.When reviewing the contents of the complaint, it is said that while injecting the drugs into his penis, the needle broke off.This is proof that there was no problem with the insulin syringe before use.This is because, in order to use an insulin syringe, drugs are sucked into the syringe using a needle, the air in the syringe is discharged using a plunger, and the needle must be checked for any abnormalities.And if the needle is bent or broken, injection into the penis itself is impossible.5.There is an inspection device in the manufacturing process, so products with bent or broken needles cannot be included.6.The original purpose of this insulin syringe is to inject insulin.It is against this purpose to inject drugs for erectile dysfunction.The fda certificate states "sure-fine insulin syringes are hypodermic insulin syringes for subcutaneous injection of u100 insulin.".
Event or Problem Description
Patient using an insulin syringe for ed injections (not indicated, but prescribed by a physician).About half of the needle broke off during the injection into the skin.

• 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: 15889898
• Report Number: 1000138447-2019-00001
• Device Sequence Number: 5258284
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022
• Report Date (Section F): 08/08/2022

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: 09/23/2022
• Event Location: Home
• Date Report to Manufacturer: 08/08/2022
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male