MAUDE Adverse Event Report: URESIL, LLC URESIL ORIGIN 10F LOCKING DRAINAGE CATHETER W/DEPT; CATHETER NEPHROSTOMY, GENERAL PLASTIC SURGERY

Catalog Number GPL2-1030H

Device Problems Leak/Splash (1354); Defective Component (2292)

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

Event Date 08/09/2019

Event Type  Injury  

Event Description

Pt was transported to inpatient ultrasound area for intervention radiology procedure.The procedure was performed as usual and upon completion, it was discovered the uresil 10 fr pigtail catheter was defective.The locking component that attaches to the accordion drainage bag was leaking.Attempts were made to reattach the bag but were unsuccessful.The physician chose to replace the catheter at a later time after a 2nd catheter from the same lot malfunctioned.Fda safety report id# (b)(4).

• Brand Name: URESIL ORIGIN 10F LOCKING DRAINAGE CATHETER W/DEPT
• Type of Device: CATHETER NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): URESIL, LLC
• MDR Report Key: 8907348
• MDR Text Key: 155006563
• Report Number: MW5089147
• Device Sequence Number: 2
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: GPL2-1030H
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR