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

Model Number G23259

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2022

Event Type  malfunction  

Event Description

Straight blood set, product# 2c6700, lot# (10) r22d06048, administering 1 bag of platelets.Tubing primed, but connector on end of tubing would not connect to male adapter plug, or any other port on any another tubing tried.New set opened and worked appropriately.Approximately 30ml platelets "lost" in first primed set.

• Brand Name: COOK
• 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: 15645269
• MDR Text Key: 302167234
• Report Number: 15645269
• 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: 10/05/2022

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 Model Number: G23259
• Device Catalogue Number: C-UTLMY-701J-CCT-A-RD
• 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: 10/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1