MAUDE Adverse Event Report: COOK INC VENTRICLEAR DRAINAGE CATHETER SET NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)

Model Number G44130

Device Problem Fluid Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: principal quality engineer. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that while using a cook ventricular drainage catheter, cerebrospinal fluid leaked around the catheter where the stitches were placed. Additional information regarding the patient, device, and event has been requested but is currently unavailable.

• Brand Name: VENTRICLEAR DRAINAGE CATHETER SET
• Type of Device: NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10547141
• MDR Text Key: 207373342
• Report Number: 1820334-2020-01703
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/10/2022
• Device Model Number: G44130
• Device Catalogue Number: 50318
• Device Lot Number: NS13037539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial