MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL IV CATH 22GX1"; IV CATHETER

Catalog Number	26746
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted on product # 26746, lot # 240902, which included the following: incoming inspection an incoming inspection has been performed in accordance with sop-11 incoming inspection procedure on product # 26427, lot #240902.The batch met the established criteria for product release, and no nonconformities were identified.Production process review the batch records of the production process and the finished product inspection reports were reviewed.No changes to raw materials, production processes, or inspection methods were identified.All reviewed documentations complied with product release standards requirements and the finished products met all specified acceptance criteria.No abnormalities or non-conformities were found.Retained samples inspection fifty retained samples of indwelling catheters from product # 26746, lot #240902 were subjected to visual inspection.All samples were found to be clean and free of foreign matter.Additionally, five samples from the retained samples underwent visual inspection of the needle tubes.No visible accumulation of lubricant or liquid droplets was observed.Cause analysis based on the customer's description, it is likely that the "liquid/water" is the accumulation of silicon oil lubricant over time, which may appear as liquid or water-like droplets.Such accumulation is difficult to detect during the production process because the material may require time before becoming visible.The lubricant used in the product is dimethyl silicon oil, which has been previously evaluated through biological evaluation and has been determined to be suitable for intended clinical use.However, the customer did not return the samples for, conformity testing could not be performed.Based on the available data, the exact root cause could not be determined.Potential explanation could be a localized accumulation of silicon oil; however, this remains unconfirmed.This complaint will be closed in our system.No similar complaints within the lot.(b)(4).
Event or Problem Description
Customer reported using 22g catheters and when they opened the cap from the seal there was visible water/liquid.No adverse event noted as the issue was discovered before used on a patient.

• Brand Name: EXEL IV CATH 22GX1"
• Common Device Name: IV CATHETER
• 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: 25246222
• Report Number: 1035907-2026-00053
• Device Sequence Number: 9597309
• Product Code: FOZ
• UDI-Device Identifier: 00020221267464
• UDI-Public: (01)00020221267464(17)290802(30)1(10)26746
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K895768
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 26746
• Device Lot Number: 240902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/21/2026
• 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