MAUDE Adverse Event Report: ALLISON MEDICAL INC. SURE COMFORT INSULIN SYRINGES 3/10CC 5/16" LENGTH 31 GAUGE NEEDLE; NEEDLE, HYPODERMIC, SYRINGE LUMEN

Model Number	22-6503
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
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.

• Brand Name: SURE COMFORT INSULIN SYRINGES 3/10CC 5/16" LENGTH 31 GAUGE NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SYRINGE LUMEN
• Manufacturer (Section D): ALLISON MEDICAL INC.
• MDR Report Key: 8014248
• Report Number: MW5080870
• Device Sequence Number: 1189831
• Product Code: FMI
• UDI-Device Identifier: 00786227650357
• UDI-Public: (01)00786227650357
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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 Expiration Date: 02/28/2023
• Device Model Number: 22-6503
• Device Lot Number: 180320AS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR