MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR SPECIAL EVD 10-110 W/O Y SITE; N/A

Catalog Number SP0090

Device Problem Break (1069)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 06/05/2019

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 medwatch form with uf/importer report #: (b)(4) was received with the following information: on (b)(6) 2019, an (b)(6) old female patient had an external ventricular drain and was found to be broken at the point where the transducer attaches to the buretrol.Cerebrospinal fluid found to be dripping out.No patient harm was noted.Patient was alert and talking.Ventric was clamped to patient and sterile gauze was wrapped around both open ports in the system to prevent infection.A new ventriculostomy was set up per protocol and neurosurgeon was at bedside to replace unit.Additional information has been requested.

Manufacturer Narrative

Updated fields: g4, g7, h2, h3, h6, h10.Udi number: (b)(4).The root cause for the stopcock breakage was due to a modification made to the mold by the supplier stopcock p/n 20580-001.The supplier mold change resulted in a reduction in the wall thickness at the junction between the port and the stopcock body.Recall res #82659 was initiated by integra.An advisory notice with precautions were sent to impacted customers in april of 2019.Since the implementation of the new stopcock design (p/n 20722-001) on october 15th, 2019, the monitorr and limitorr products have not been subject to complaints of broken stopcock.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 229048 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 (b)(4) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: SPECIAL EVD 10-110 W/O Y SITE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• MDR Report Key: 10275758
• MDR Text Key: 202937316
• Report Number: 2648988-2020-00010
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K920156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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 Expiration Date: 11/30/2020
• Device Catalogue Number: SP0090
• Device Lot Number: 3291037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: RES 82659
• Patient Sequence Number: 1
• Patient Age: 18 YR