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

Model Number GPL2-1030H

Device Problem Material Puncture/Hole (1504)

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

Event Date 12/10/2019

Event Type  malfunction  

Event Description

Drainage catheter had pinhole in hub that couldn't hold suction.Abscess tube placement in ct scan, tube placed and when suction bulb was attached to catheter it was noticed that the suction bulb was loosing suction.Connections were checked, it was discovered that the drainage catheter was the cause of the loss of suction.A new catheter needed to be placed.Pinhole was confirmed by inserting fluid through the explanted catheter while occluding the tube.

• Brand Name: URESIL GENERAL PURPOSE LOCKING DRAINAGE CATHETER
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): URESIL LLC ; 5418 w touhy ave; skokie IL 60077
• MDR Report Key: 9569266
• MDR Text Key: 174671343
• Report Number: MW5092109
• Device Sequence Number: 1
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/20/2019

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 Operator: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: GPL2-1030H
• Device Catalogue Number: GPL2-1030H
• Device Lot Number: 9F453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 100