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

Catalog Number 910112A

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/22/2019

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.

Event Description

A distributor reported on behalf of the customer that the collector cup of the 910112a external ventricular drainage set (evds) was leaking at the bottom on (b)(6) 2019.The problem seemed to be at the junction of the bottom with the bottle wall.There was patient contact with no patient injury reported.However, revision/medical intervention was required.There was no delay in surgery.The product was not released for "withdrawal".Additional information has been requested.

Manufacturer Narrative

Additional information received on 10dec2019 indicating that there was no delay in surgery noted and a replacement of the device was used to complete the procedure.It was reported that the patient's status was currently stable.The device was not returned for evaluation.The device history record were reviewed and did not reveal any anomaly that could explain the reported event.During the manufacturing process a leakage test is performed on 100% of the devices.Controls also include an occlusion test to verify the strength of the solvent bond joints (pull test) of the patient line and burette lines.In addition, at final release, a sampling of 5 units is tested for leakage conditions.The filter cap issues encountered at incoming inspection would not cause drained fluid to leak when the devices was used as intended.The instructions for use caution ¿do not overfill the cylinder.Keep the cylinder and the check valve upright at all times.¿ ¿do not tip drainage cylinder while inside of cylinder is wet.Do not allow cylinder filter to become wet¿.The review of integra complaint tracking database since 2016 reveals a leakage complaint rate of (b)(4) for eds products family (basis of (b)(4) devices shipped from manufacturing site).The complaint was verified as valid.Udi di: (b)(4).Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr (b)(4) and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted donna engleman, director of regulatory programs, office of product evaluation and quality and michelle rios, assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: EXTERNAL VENTRICULAR DRAINAGE SET (EVDS)
• 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: 10276832
• MDR Text Key: 202584491
• Report Number: 9612007-2019-00043
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 910112A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1