MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY

Model Number 228707

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2021

Event Type  malfunction  

Event Description

Place nephrostomy tube in mid-september into right kidney.Cook multipurpose drain 12fr, 25cm tube has been leaking since insertion.Unsecure connection discovered between hub and tubing.Required replacement.

• Brand Name: COOK
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12680903
• MDR Text Key: 277921944
• Report Number: 12680903
• 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: 10/14/2021

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: No Information
• Device Model Number: 228707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA