MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL IV CATH 22GX1"; Catheter, intravascular, therapeutic, short-term less than 30 days

Catalog Number	26746
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An incoming inspection was performed on product # 26746, lot #240401 following sop-11 incoming inspection procedure.This lot met the the inspection criteria for product release, with no abnormalities noted.The cmo conducted an investigation that included the following:production process review: the batch production review and finished product release inspection report for this batch were reviewed.There were no changes in raw materials or production process, and the finished product passed the release inspection.No non conformities were observed.Retained sample testing:appearance inspection: ten (10) retained samples from this lot were tested for visual or appearance inspection.All tested samples complied with the requirements, and all components of the product were properly assembled without ay detachment or damage observed.Seal integrity testing: five (5) samples were selected for seal integrity testing.All tested samples complied with the test criteria, with no air leakage noted.Simulated clinical testing: five (5) samples were selected for simulated clinical testing.All tested samples met the requirements for simulation tests, and no liquid leakage was found.Cause analysis based on the photos submitted, the following possible scenario may have occurred.The needle hub may have been accidentally pulled out during clinical use, creating a gap between the catheter and the needle.This could have allowed blood to flow from the peripheral catheter into the catheter hub, resulting in blood leakage.The peripheral hub assembly may have been damaged which could also lead to a blood leakage.However, these causes could not be confirmed due to the absence of the defective device to examine.Based on available information, we were unable to determine the root cause, and/or unable to replicate the issue in our investigation.Therefore, the root cause remains unconfirmed.This complaint can now be closed.No similar complaints found in the lot.
Event or Problem Description
The plastic part of the catheter (in the vein) was not properly connected to the external plastic and the patient (sedated for cohat or veterinary pet) bled from that junction.Our major concern was that the internal portion could have broken off and caused serious harm or death to the patient.We noticed the bleeding around it and removed the catheter promptly.

• Brand Name: EXEL IV CATH 22GX1"
• Common Device Name: Catheter, intravascular, therapeutic, short-term less than 30 days
• Manufacturer (Section D): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach 90278
• Manufacturer (Section G): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach
• Manufacturer Contact: vu doan ; 2500 santa fe avenue; redondo beach 90278
• MDR Report Key: 23428707
• Report Number: 1035907-2025-00038
• Device Sequence Number: 12825244
• Product Code: FOZ
• UDI-Device Identifier: 00020221267464
• UDI-Public: (01)00020221267464(17)290301(30)1(10)240401
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 26746
• Device Lot Number: 240401
• 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: 10/02/2025
• Initial Report FDA Received Date: 10/30/2025
• 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