MAUDE Adverse Event Report: EXELINT INTERNATIONA, CO TANDEM DIABETES 3ML LL WITH CO-PACKED NEEDLE 26GX3/8"KDL; SYRINGE WITH NEEDLE

Model Number	1001215
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Caller reported they could not draw air in or out of the syringe.While trying to do so customer accidentally stabbed their finger with the need and injected air into themselves.Customer went to the er and doctor did not have to take any action upon observation.No substantial damage occurred to the patient.
Additional Manufacturer Narrative
An investigation of the issue that included the following: retained samples were examined that included the following: five randomly retained samples were selected from this specific batch for simulated aspiration and injection tests.No issues with aspiration and injection were found.Additionally, a review of the production process, finished product inspection, and incoming inspection f the injection needles were conducted, and no abnormalities were identified in the injection needles.Product records - the records related to product 1001215 lot 240508, product records and inspection report were reviewed.All documents were found to be acceptable, and no nonconformities.Based on the investigation, the reported issue could not be reproduced.No defects or abnormalities were found in the retained samples, and no nonconformities were identified.(b)(4).

• Brand Name: TANDEM DIABETES 3ML LL WITH CO-PACKED NEEDLE 26GX3/8"KDL
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): EXELINT INTERNATIONA, CO; 2500 santa fe ave.; redondo beach 90278
• Manufacturer (Section G): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach CA 90278
• Manufacturer Contact: vu doan ; 2500 santa fe avenue; redondo beach 90278
• MDR Report Key: 23418518
• Report Number: 1035907-2025-00037
• Device Sequence Number: 18749809
• Product Code: FMF
• UDI-Device Identifier: 00020221261158
• UDI-Public: (01)00020221261158(17)290408(30)1(10)240508
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K861153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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 Model Number: 1001215
• Device Lot Number: 240508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization
• Patient Sex: Female