MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8''; SYRINGE WITH NEEDLE

Lot Number	250523
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Issue: caller reported needle damage: "needle exploded off of syringe when trying to push air out from syringe after removing air from cartridge" injury: there were no injury or consequences from caller.Resolution: replacement of needle and/or syringe.
Additional Manufacturer Narrative
*this lot was investigated in ir # 20260224.*retained samples were tested and analyzed for visual inspection, simulated suction, simulated injection, observation under static conditions, as well as review of factory inspection data.All samples tested and analyzed passed all inspections and were deemed qualified, with no quality defects observed.* all relevant documents ( batch production records, finished product inspection, process control, incoming inspection, inspection and testing) corresponding to the tested lot were carefully reviewed and found to comply with product release requirements, with no abnormalities found.*the incoming inspection for this was performed in accordance to sop-11 incoming inspection procedure.These lots passed the acceptance criteria for product release, with no abnormalities detected.*for this lot the issues have been investigated, and no device issues have been found any complaints for the same issues.*the products in question were not returned for investigation.*no documentary evidence such as photos or videos were provided with this complaint.*based on available information and manufacturing investigation, no device problem has been found.This complaint can now be closed.*to address this proactively: we will continuously review and monitor this type of complaint, this incident will be added to our list of complaints for tracking and trend analysis, and we will work to improve communication and collaboration with tandem to enhance data collection and gathering process.*no similar complaints within the lot.(b)(4).

• Brand Name: 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8''
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach CA 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, CA 90278 ; 3106490707
• MDR Report Key: 24945518
• Report Number: 1035907-2026-00046
• Device Sequence Number: 9853647
• Product Code: FMF
• UDI-Device Identifier: 20020221012150
• UDI-Public: (01)20020221012150(17)300123(30)1000(10)250523(240)1001215
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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 Lot Number: 250523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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
• Patient Sex: Unknown