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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 06/18/2015

Event Type  Injury  

Manufacturer Narrative

Lot number not provided by the reporter.Expiration date unknown as lot number is unknown.Udi #: unknown as lot is unknown.(b)(4).Event is still under investigation.Corrected data from user facility: date of report: 08/03/2015.Brand name: ventriclear drainage catheter set.Common device name: nhc catheter, ventricular (containing antibiotic or antimicrobial agents).Date user facility or importer became aware: 06/18/2015.Date of this report: 06/xx/2015.Date report sent to fda: 06/xx/2015.

Event Description

From voluntary medwatch report provided by another manufacturer: attempted removal of an external ventricular drain (evd), met with resistance, and on third attempt made by different surgeon while applying pressure, evd snapped.Patient taken to or for removal of remaining of drain.No sequalee.Patient discharged home next day.".

Manufacturer Narrative

Lot number not provided by the reporter.Expiration date unknown as lot number is unknown.Udi #: unknown as lot is unknown.(b)(4).Corrected data from user facility: ventricular drainage catheter set.Nhc catheter, ventricular (containing antibiotic or antimicrobial agents) investigation / evaluation: no product was returned; however, a review of the complaint history, device history record, instructions for use (ifu) and quality control (qc) was conducted during the course of investigation.Per quality control specification, there is a confirmation that the surface of the catheter is free of damage, dirt and foreign debris.This product is shipped with an instructions for use (ifu); which states contraindications, warnings, precautions and instructions for use.Based on the information provided, the catheter met resistance upon removal from the patient.It is possible that the catheter was exposed to forces beyond its design.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera); no further risk reduction is required.

Event Description

From voluntary medwatch report provided by another manufacturer: attempted removal of an external ventricular drain (evd), met with resistance, and on third attempt made by different surgeon while applying pressure, the evd snapped.The patient taken to or for removal of remaining drain.No sequalee.Patient discharged home next day.

• 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5031138
• MDR Text Key: 24069207
• Report Number: 1820334-2015-00534
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 50318
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2015
• Event Location: Hospital
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR