MAUDE Adverse Event Report: COOK INCORPORATED KUMPE ACCESS CATHETER; CATHETER, UROLOGICAL

Lot Number 14746627

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/05/2022

Event Type  malfunction  

Event Description

We were doing a ureteral stent placement and i gave another person a cook kmp catheter and she was unable to thread the wire because the catheter was flat/defective.I gave her a new one and it was also defective.I then opened one from a different lot and it was fine.The defective catheter never touched the patient.

• Brand Name: KUMPE ACCESS CATHETER
• Type of Device: CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 15191658
• MDR Text Key: 297526608
• Report Number: 15191658
• Device Sequence Number: 1
• Product Code: FAD
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 14746627
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male