MAUDE Adverse Event Report: URESIL 8FR NEPHROSTOMY TUBE

Model Number NCL2-0835HB

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 12/06/2017

Event Type  Injury  

Event Description

Uresil 8fr nephrostomy tube comes detached from hub.This has happened on every one of these devices we have implanted.

• Brand Name: 8FR NEPHROSTOMY TUBE
• Type of Device: 8FR NEPHROSTOMY TUBE
• Manufacturer (Section D): URESIL; skokie IL 60077
• MDR Report Key: 7104595
• MDR Text Key: 94492119
• Report Number: MW5073887
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: NCL2-0835HB
• Device Lot Number: 7E459
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 65