MAUDE Adverse Event Report: COOK INCORPORATED COOK SPECTRUM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number G49803

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

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

Event Date 07/23/2021

Event Type  malfunction  

Event Description

Er physician was trying to place a triple lumen femoral line, and the catheter in the kit was bent.This was how she found it in the kit, it did not occur from trauma during the procedure.She did try to use the catheter still but was unsuccessful, as it bent the guide wire.

• Brand Name: COOK SPECTRUM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12323848
• MDR Text Key: 266680853
• Report Number: 12323848
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 08/04/2021

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: Health Professional
• Device Model Number: G49803
• Device Catalogue Number: C-UTLMY-701J-ABRM-HC-IHI-FST-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Weight: 61