MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number G02089

Device Problem Packaging Problem (3007)

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

Event Date 10/07/2018

Event Type  malfunction  

Event Description

Look alike packaging.While restocking, the rn noticed that the packaging for the two catheter sets were identical with the exception of the name.The concern is that since the packaging looks the same, the wrong catheter could be pulled and possibly used in an emergent situation.

Event Description

Look alike packaging.While restocking the rn noticed that the packaging for the two catheter sets were identical with the exception of the name.The concern is that since the packaging looks the same the wrong catheter could be pulled and possibly used in an emergent situation.

• Brand Name: COOK
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7999170
• MDR Text Key: 124952987
• Report Number: 7999170
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G02089
• Device Catalogue Number: C-PMS-401J-FA
• Device Lot Number: 8904123
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1