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

Model Number GPL2-1230H

Device Problem Crack (1135)

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

Event Date 10/07/2019

Event Type  malfunction  

Event Description

The drain placed and hooked to jp bulb- bulb unable to hold air, disconnected and hub was cracked.Manufacturer response for drainage cath 12f, (brand not provided) (per site reporter).Rep reported to manufacturer, he will pick-up and return for evaluation.

• Brand Name: GP GENERAL PURPOSE 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: 9174161
• MDR Text Key: 161803446
• Report Number: 9174161
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GPL2-1230H
• Device Catalogue Number: GPL2-1230H
• Device Lot Number: 9E440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA