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 01/09/2019

Event Type  Injury  

Manufacturer Narrative

The device is not expected 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.Linked to mfg.Report numbers: 9612007-2019-00005 and 9612007-2019-00007.

Event Description

This is 2 of 3 reports.This is in regards to the second patient.A distributor reported on behalf of the customer that there was leakage of the 91011a external drainage set (eds).The device was in contact with the patient.There was no patient injured.The event led to an increase in surgery time.Additional information received on (b)(6) 2019 indicated that the items in question were only released to the operating room and some of the wards in (b)(6) and (b)(6).Majority of the stock was used for emergency cases and with the night staff.It was reported that the 'junior surgeons' assumed the leak from the burettes of the 910110a was their fault (thinking it was their surgical technique errors) and just changed the external ventricular drain (evd).They did not report the problem to their seniors.The first complaint to the distributor was (b)(6) 2019 when the neuro charge witnessed the problem and recorded the batch.They did three (3) cases (3 patients) on the morning of (b)(6) 2019 and discarded seven (7) units due to leaks.

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: 8294813
• MDR Text Key: 134740729
• Report Number: 9612007-2019-00006
• 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,health pr
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• 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: 2788074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1