MAUDE Adverse Event Report: COOK INCORPORATED COOK; INTRODUCER, CATHETER

Model Number G57485

Device Problems Material Frayed (1262); Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Event Description

The proximal and distal portions of the catheter in the liver biopsy kit were defective.The catheter was removed without incident or harm.Catheter frayed at the bottom.The luer lock part at the top fell off.

• Brand Name: COOK
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12266229
• MDR Text Key: 264706217
• Report Number: 12266229
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57485
• Device Catalogue Number: LABS-100-J-01
• Device Lot Number: 13589436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA