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 10/24/2018

Event Type  Injury  

Manufacturer Narrative

The device was not yet 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

An integra account manager reported on behalf of the customer that the luer lock of the sp0090 special evd 10-110 w/o y site sheared off, specifically where the transducer was connected on (b)(6) 2018.The device was used on a (b)(6) year old female patient.There was no injury and surgery delay noted.Additional information was received on 06dec2018 stating that there was cerebrospinal fluid (csf) leak noted from the port which alerted the staff to the problem.The customer also mentioned that similar breakage at the transducer stopcock has occurred at least five other times in the last year; however, the customer did not provide any further details on it.

Manufacturer Narrative

The product was not returned for evaluation.No device history record (dhr) review was possible since no lot number was provided.The failure analysis is also not possible due to unavailability of the product.The reported complaint was not confirmed.Therefore, the root cause analysis is undetermined.

Event Description

N/a.

• 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: 8184367
• MDR Text Key: 131008340
• Report Number: 2648988-2018-00055
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP0090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR