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

Model Number	G23655
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Cook catheter central venous catheter trays manufactured after march 1, 2021 do not have the 22ga needle/25ga needle inside the kit as listed on the contents list.A letter was sent to material warehouse with notification of supply shortage issue as reason kits do not have needles present.The information was not distributed to the end user level from materials management.Providers are sterile and in process of inserting the central line and preparing to draw up lidocaine for local anesthesia when discover the needles are not present.A delay in insertion occurs while another staff member obtains needles.A label on the outside of the package would notify the end user of which items currently missing in the kit and allow end user to obtain needed items prior to insertion and preventing delays.

• Brand Name: COOK SPECTRUM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11919392
• Report Number: 11919392
• Device Sequence Number: 3304385
• Product Code: FOZ
• UDI-Device Identifier: 00827002236554
• UDI-Public: (01)00827002236554(17)220101(10)13691470
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2021
• Report Date (Section F): 05/18/2021

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
• Operator of Device: No Information
• Device Model Number: G23655
• Device Catalogue Number: C-UTLMY-701J-ABRM-CUSTOM-0022
• Device Lot Number: 13691470
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/18/2021