MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA EXTERNAL DRAINAGE SET (EDS); EXTERNAL DRAINAGE SYSTEMS

Catalog Number 910110A

Device Problem Leak/Splash (1354)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device is going to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A distributor reported on behalf of the customer that there was leakage reported on the 910110a external drainage set.Additional information was received on 14jan2019 indicating that there were 2 units of the 910110a that did not function correctly on the male patient before the customer decided to use a different batch.Operating room time increased to one hour and 20 minutes due to the product problem where an external ventricular drain change should only take up to 45 minutes.The date of the incident was on (b)(6) 2019.It was reported that the standard procedure is for all taps to be closed during connection to the ventricular catheter and then burette and drainage bag is secured to an intravenous (iv) stand; while the patient is on operating room bed and same procedure is followed during transportation to the intensive care unit (icu).Stop cocks are opened once system is connected and secured to the iv stand.There was no patient injury reported.However, a leak was noted immediately when cerebrospinal fluid (csf) entered the burette.The location of the leak was detected on the top of the burette; before entering the burette.

Manufacturer Narrative

Four (4) units were received for evaluation.External ventricular drainss (product id 910110a) do not have labels on the device; thus, the lot numbers could not be confirmed.The samples were still humid/wet from decontamination process with cidex.The units were installed on an iv pole in a vertical position and colored water was passed through the entire system.Special attention was given to the burette top cap; nonetheless, no leaks were observed in the fluid pathway.The reported condition was unconfirmed.No further evaluation is possible at this moment since the condition could not be reproduced.

Manufacturer Narrative

Additional information received on 31jan2019: for evd change, the drainage set is attached to the ventricular catheter when the patient is already on the icu bed-which has an iv pole attached to it (bed).So immediately in a vertical position.If it is a tumor case-csf drainage needs to be observed during the case and the drainage set is attached in a vertical position to a mobile iv stand in theatre.This is standard practice for this neurosurgical unit.The leakage was noted when csf reached the burette, so immediately when csf flowed from ventricular catheter to drainage set.The leak occurred on top of the burette where the inlet is.The complaint unit was not returned for evaluation.According to the dhr review, no anomaly was reported during the manufacturing process that could be related to the reported condition.The reported condition is unconfirmed.The root cause is undetermined at this moment.Udi device identifier: (b)(4).Product identifier: (b)(4).

• Brand Name: EXTERNAL DRAINAGE SET (EDS)
• Type of Device: EXTERNAL DRAINAGE SYSTEMS
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• MDR Report Key: 8291035
• MDR Text Key: 134565748
• Report Number: 9612007-2019-00004
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K032817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 910110A
• Device Lot Number: 2850000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1