MAUDE Adverse Event Report: SURE COMFORT; INSULIN SYRINGE

Model Number	22-6505
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's father, states that the syr/needle combo that we have sent with the patients salzen (the needle) has broken 3x in the patient's leg per father's request, please dc all ndls and syr for the pt salzen due rph.

• Brand Name: SURE COMFORT
• Common Device Name: INSULIN SYRINGE
• MDR Report Key: 15915337
• Report Number: 1000138447-2022-00003
• Device Sequence Number: 4702178
• Product Code: FMF
• UDI-Device Identifier: 00786227650555
• UDI-Public: 00786227650555
• Combination Product (Y/N): N
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

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: 22-6505
• Device Catalogue Number: 22-6505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2022
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2022
• 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 Sex: Male