MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL 5ML SYR ONLY L-L, W/CAP; SYRINGE ONLY

Catalog Number	26230
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The customer states that the wings and bands are weak.The wing was so small and flimsy, it was hard to get a grip and push the medicine through the needle.No adverse event to the patient.

• Brand Name: EXEL 5ML SYR ONLY L-L, W/CAP
• Common Device Name: SYRINGE ONLY
• 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: 25113839
• Report Number: 1035907-2026-00049
• Device Sequence Number: 9218781
• Product Code: FMF
• UDI-Device Identifier: 00020221262308
• UDI-Public: (01)00020221262308(17)300107(30)1(10)26230
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2026

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
• Device Catalogue Number: 26230
• Device Lot Number: 250207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/28/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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