MAUDE Adverse Event Report: UNKNOWN NEPHROSTOMY TUBE; CATHETER, NEPHROSTOMY

Model Number UNKNOWN

Device Problem Difficult to Insert (1316)

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

Event Date 01/28/2020

Event Type  Injury  

Event Description

Patient presented to the interventional radiology department for right nephrostomy tube malfunction.Tube not inserted at this location and no information related to the date of placement.Tube has been leaking.Patient saw local urologist and referred to interventional radiology.Tube exchanged without complications.Fda safety report id # (b)(4).

• Brand Name: NEPHROSTOMY TUBE
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9659264
• MDR Text Key: 177590131
• Report Number: MW5092705
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/29/2020

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 89