MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL 2-3ML SYR 22GX1" L-L, W/ LDS; SYRINGE WITH NEEDLE

Catalog Number	26102
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been performed on product # 26102, lot number 251014 which included the following: one hundred retained samples were visually inspected.The injection needles and syringes were tightly connected, and no loosening or failure to lock was observed or found.Ten samples were randomly selected, the needles were separated from the syringes, and the internal threads were observed.The syringe threads were found to be intact without any damages.The syringes could be tightly connected with the injection needles without any issues.Production records were reviewed.No non-conformances or abnormalities were observed.The production process and raw materials remains unchanged.Tests were conducted in accordance with clause 6.5 "resistance to separation from unscrewing" of the iso 80369-7 standard.The test results meet the standard requirements.The test connection between the needle hub and the protective cap was evaluated.The protective caps were found to be secure and does not come-off naturally.An impact free pulling test was performed using an instrument.The separation force did not exceeded 15n.These tests meet the requirement established in gb15811 & iso 17864.Furthermore, the incoming inspection of this lot has been performed by following sop-11 incoming inspection procedure.This lot met the inspection criteria for product release with no abnormalities or non-conformances found.The defective device was not returned for evaluation and no documentary evidence such as photo or video was provided.No similar complaint from this lot has been reported.In summary, we were unable to determine the root cause, and or able to replicate the reported issue in our investigation.Without the physical defective device to evaluate and the lack of documentary evidence, our investigation is quite limited.Therefore, the root cause remains unconfirmed and this complaint is considered close.(b)(4).
Event or Problem Description
1 full box syringe exel 3cc ll 22x1 100s have an issue with the ll being loose and not tightening.

• Brand Name: EXEL 2-3ML SYR 22GX1" 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 90278
• Manufacturer Contact: vu doan ; 2500 santa fe avenue; redondo beach
• MDR Report Key: 22986626
• Report Number: 1035907-2025-00035
• Device Sequence Number: 21067425
• Product Code: FMF
• UDI-Device Identifier: 00020221261028
• UDI-Public: (01)00020221261028(17)291204(30)1(10)26102
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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 Catalogue Number: 26102
• Device Lot Number: 250104
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/05/2025
• 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: Unknown