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

Catalog Number INS8600

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Neurological Deficit/Dysfunction (1982); Meningitis (2389)

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, 2648988-2017-00040, 2648988-2017-00041.

Manufacturer Narrative

Additional information received on 10oct2017, 11oct2017, 30oct2017: the (b)(6) female patient had "ventriculite".It was reported that the patient had symptoms of fever, impairment of consciousness, meningitis symptoms.Bacterial culture had been done.It was not specified which of the bacterias (" ? c.Parapsilosis, s.Epidermidis, s.Capitis, e.Coli") was found on this patient.The ins8600 device was used on the patient for 8 days.Lot number of the ins8600 was unknown.The patient was treated with an antibiotic in accordance with the bacteria found.It was reported that pressure was measured on the ins8600.The ins8600 was not kept for evaluation.It was reported that the patient is alive.The customer confirmed that the ins305 is used with the ins8600.

Manufacturer Narrative

Investigation completed 11/14/2017.The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device history record review confirmed the labeling, material, and process controls were within specification.

• 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: 6886315
• MDR Text Key: 87211915
• Report Number: 2648988-2017-00039
• 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,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 Expiration Date: 02/28/2022
• Device Catalogue Number: INS8600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• 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
• Patient Age: 38 YR