MAUDE Adverse Event Report: URESIL, LLC GP GENERAL PURPOSE DRAINAGE CATHETER; CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY

Model Number GPL2-0830H

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2020

Event Type  malfunction  

Event Description

Female with large abscess between the uterus and the rectum.Interventional radiologist drained the abscess using computed tomography guided placement, "uresil drain catheter crack at the hub while hooking it to the drain bag, doctor had to exchange the catheter for a different one of a different brand.The crack caused an air leak which then we would lose the suction we would need to draw out the infection.".

• Brand Name: GP GENERAL PURPOSE DRAINAGE CATHETER
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): URESIL, LLC; 5418 west touhy ave; skokie IL 60077
• MDR Report Key: 9632290
• MDR Text Key: 176429577
• Report Number: 9632290
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GPL2-0830H
• Device Catalogue Number: GPL2-0830H
• Device Lot Number: 9F489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Weight: 47