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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHINA CORP. SURE COMFORT; INSULIN SYRINGE
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SHINA CORP. SURE COMFORT; INSULIN SYRINGE Back to Search Results
Model Number 22-6503
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Date of Event 10/24/2018
Type of Reportable Event Serious Injury
Event or Problem Description
I am an insulin dependent diabetic.I got a new box of syringes from my pharmacy, as i had used up the last box.I am having a very hard time removing the caps on this lot of syringes.My daughter (who is an emt) is also having great difficulty removing the caps so much force is needed.I have stuck my finger a few times trying to remove the cap.
 
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Brand Name
SURE COMFORT
Common Device Name
INSULIN SYRINGE
Manufacturer (Section D)
SHINA CORP.
8-26, bojeokdong-gil, useong-m
gongju-si, chungnam 32533
KS  32533
MDR Report Key15915929
Report Number1000138447-2022-00004
Device Sequence Number17242638
Product Code FMF
UDI-Device Identifier00786227650357
UDI-Public00786227650357
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/05/2022
Report Date (Section F) 11/13/2018
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 Expiration Date02/28/2023
Device Model Number22-6503
Device Catalogue Number22-6503
Device Lot Number180320AS
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/13/2018
Device Age7 MO
Event Location Home
Date Report to Manufacturer11/13/2018
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/05/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age50 YR
Patient SexFemale
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