MAUDE Adverse Event Report: COOK INCORPORATED PERFORMER; INTRODUCER, CATHETER

Model Number G10675

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2017

Event Type  malfunction  

Event Description

A check-flo performer introducer had a defective valve which allowed an unacceptable amount blood leakage from a dialysis fistula.This had to be replaced as soon as it was inserted.

• Brand Name: PERFORMER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6954309
• MDR Text Key: 89499914
• Report Number: 6954309
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2017,10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/11/2020
• Device Model Number: G10675
• Device Catalogue Number: RYCFW-6.0-35-6-RB-CW
• Device Lot Number: 7905146
• 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: 10/03/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR