MAUDE Adverse Event Report: URESIL, LLC; CATHETER, DRAINAGE

Catalog Number GPL1-1230H

Device Problems Crack (1135); Suction Problem (2170)

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

Event Date 07/07/2017

Event Type  malfunction  

Event Description

Crack at hub of drain airleak jp.Drain needed to be removed 2* to crack at hub and inability for bulb to hold suction.Manufacturer response for catheter, (brand not provided) (per site reporter): took description of problems and issued rga#.

• Type of Device: CATHETER, DRAINAGE
• Manufacturer (Section D): URESIL, LLC; 5418 west touhy ave; skokie IL 60077
• MDR Report Key: 6803600
• MDR Text Key: 83024948
• Report Number: 6803600
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: GPL1-1230H
• Device Lot Number: 7372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR