MAUDE Adverse Event Report: URESIL, LLC GP GENERAL PURPOSE DRAINAGE CATHETER

Model Number	GPL2-1230H
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	High White Blood Cell Count (4594); Bacteremia (4846)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product not available; not able to examine the device.Uresil's risk management indicates a potential failure/hazard of catheter hub fails (e.G., breaks, cracks, detaches, including when engaged by user for flushing / attachment of drainage collecting device or other drainage accessory), which is assigned degree of severity "negligible" and acceptable rate of occurrence "1 in 1000 (occasional)": "luer cracks when engaged by user for flushing/attachment of drainage collecting device or other drainage accessory" with potential outcome "might require catheter replacement." this can occur when the luer is overtightened when the user is attempting to ensure a leakproof connection.Trend analysis of complaints indicates that the occurrence rate of cracked luer is below that indicated as acceptable in risk management as well as below the threshold set in quality objectives/metrics.No issues noted in manufacturing records.100% catheter pressure leak testing is performed on assembled products to ensure the catheter does not leak above specification values.Regular pull and torque testing is performed on the assembled catheter hub to ensure strength and torque characteristics are within specifications.Injection molding and process validation has been performed on the catheter hub and luer assembly to ensure effectiveness and repeatability of the processes performed.The ifu states not to overtighten the connection when engaging the luer.These steps mitigate the risk of this hazard as far as possible.
Event or Problem Description
Narrative from healthcare facility: patient presenting with persistent rlq periappendiceal abscess, associated recurrent infection, and broken/malfunctioning percutaneous drain.The current management framework is to have this cavity fully drained and collapsed and then to undergo interval appendectomy.On initial admission exam, hr in 120s, no measured fever in ed, very tender in rlq.Drain not holding suction (luer lock cracked).Wbc 20.Sepsis fluids initiated.Ct scan demonstrates persistent (but decreased) walled-off abscess.Previous 8cm, now 5cm.The hub [luer] of the drain was fractured.Therefore, the jp [jackson-pratt] bulb could not be attached to effectively drain the abscess.The drain malfunction directly lead to abscess progression, elevated white blood cell count and fever.The clinical picture was consistent with bacteremia.The patient became so ill, that she could not wait for outpatient treatment.She came to the er and was directly admitted to the hospital.Patient has since been discharged from the hospital.

• Brand Name: GP GENERAL PURPOSE DRAINAGE CATHETER
• Common Device Name: GENERAL PURPOSE DRAINAGE CATHETER
• Manufacturer (Section D): URESIL, LLC; 5418 w touhy ave; skokie IL 60077
• Manufacturer (Section G): URESIL, LLC; 5418 w touhy ave; skokie IL 60077
• Manufacturer Contact: courtney wallace ; 5418 w touhy ave; skokie, IL 60077 ; 8479820200
• MDR Report Key: 22030987
• Report Number: 1450395-2025-00001
• Device Sequence Number: 8142019
• Product Code: GBO
• UDI-Device Identifier: 00817640020066
• UDI-Public: 00817640020066
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GPL2-1230H
• Device Catalogue Number: GPL2-1230H
• Device Lot Number: 4G750
• 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: 05/09/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 70 KG