MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL 2-3ML SYR 25GX1" L-L, W/ LDS; SYRINGE WITH NEEDLE

Catalog Number	26111
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The cmo conducted an investigation on product#: 26111, lot#: 210615 and the results are as follows: production process review: the batch production records, factory inspection, and testing of products were reviewed.All documents were found to be acceptable for product release, with no abnormalities observed.Retained samples testing: one hundred retained samples were each visually inspected.The samples met the inspection with no abnormalities were observed.Five samples were randomly selected for simulated aspiration and injection tests.All tested samples passed the tests with no leakage or ejection issues were found.Additionally, an observation was performed on the tested sample syringes by separating or disconnecting the syringe from the needle hub.The syringe's threaded port and the injection needle hub were found to be intact and securely fitted.The incoming inspection has been conducted on product#: 26111, lot#: 210615 in accordance with sop-11, incoming inspection procedure.The lot passed the incoming inspection criteria for product release.Minor non-conformity was observed, however, this was documented and determined to be unrelated to the reported issue base.On available evidence.In summary, all retained samples were found to be qualified for product release with no needle detachment or breakage detected in the tested samples.It is likely possible that the connection between the syringe's threaded port and needle hub may be loosened; however, this could not be confirmed based on the available information.Therefore, we were not able to determine the root cause, and it remains unconfirmed.
Event or Problem Description
The customer reported that when they administer b12 shot, the syringe was leaking from the hub.After discarding the defective syringe, she used another one and the needle popped-off, so she tested another syringe with a lemon , and the needle popped off again in the lemon.The customer mentioned that no patients were injured as a result of the event.

• Brand Name: EXEL 2-3ML SYR 25GX1" L-L, W/ LDS
• 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: 22419903
• Report Number: 1035907-2025-00031
• Device Sequence Number: 8663352
• Product Code: FMF
• UDI-Device Identifier: 00020221261110
• UDI-Public: (01)00020221261110(17)260515(30)1(10)210615
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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 Expiration Date: 05/15/2026
• Device Catalogue Number: 26111
• Device Lot Number: 210615
• 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: 06/09/2025
• Initial Report FDA Received Date: 07/07/2025
• 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: Female