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

Model Number G43991

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2018

Event Type  malfunction  

Event Description

Central venous catheter tray had a defective introducer needle that would not stay on syringe prior to use on patient. A new tray was opened and the needle in that kit worked appropriately.

• 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: 8054790
• MDR Text Key: 126654642
• Report Number: 8054790
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G43991
• Device Catalogue Number: C-UDLMY-401J-ABRM-HC-FST
• Device Lot Number: 8603966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage