MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY; N/A

Catalog Number INS8600

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Meningitis (2389); Fungal Infection (2419)

Event Type  Injury  

Event Description

During (b)(6) 2017, the critical care department in neurosurgery of (b)(6) has seen an increase of meningitis infection which concerned patients with an external ventricular drainage system (evd).The number of patients infected is 5.The only change was the use of the new evd (8600) since (b)(6) 2017.Most of the infection has bacteria origin but one case was yeast.One of the patients has neurological after-effects.According to the hospital, the infectious risk is linked to the use of the device due to opening of a closed system when changing the drainage bag.No devices have been kept for evaluation purpose.A hygienic investigation is in progress at the hospital.Linked to mfg.Report numbers: 2648988-2017-00037; 2648988-2017-00038; 2648988-2017-00039; 2648988-2017-00041.

Manufacturer Narrative

This follow up mdr is being sent to report that there should not have been an initial mdr filed under mfg.Report number 2648988-2017-00040.Customer initially reported that there were 5 patients with meningitis.Initial mdr with mfg.Report number 2648988-2017-00040 was sent for the 4th patient.Customer clarified on 11oct2017 that there were only three patients involved and not five.The three patients were already captured under mfg.Report numbers: 2648988-2017-00037, 2648988-2017-00038, and 2648988-2017-00039.

• Brand Name: CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY
• 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
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6886313
• MDR Text Key: 87214307
• Report Number: 2648988-2017-00040
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K972994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS8600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other