MAUDE Adverse Event Report: COOK INCORPORATED MULTIPURPOSE DRAINAGE CATHETER ULTRATHANE; CATHETER, NEPHROSTOMY

Model Number G09502

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

Drainage procedure performed by attending radiologist.Radiologist inserted 10.2fr multipurpose drainage catheter into patient.After placement, radiologist determined that the drain was leaking at the hub.Drain had to be removed and another drain inserted to complete the procedure.

• Brand Name: MULTIPURPOSE DRAINAGE CATHETER ULTRATHANE
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 17224216
• MDR Text Key: 318095416
• Report Number: 17224216
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2023

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: G09502
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 15236688
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic