MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL EVD CATHETER; BACTISEAL EVD CATHETERS

Catalog Number 821745

Device Problem Insufficient Information (3190)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 02/25/2024

Event Type  Injury  

Event Description

A facility reported: following wash and clean linen noticed yellow wet stain on the sheet underneath the evd clamp closest to the patients head as there had been no breaks to the evd circuit.Chlorohexidine soaked gauze placed over evd clamp to keep it sterile.Neurosurgeons replaced evd set".

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: CODMAN BACTISEAL EVD CATHETER
• Type of Device: BACTISEAL EVD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18949724
• MDR Text Key: 338244673
• Report Number: 3013886523-2024-00080
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K102589
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 821745
• Device Lot Number: 7275609
• Date Manufacturer Received: 02/27/2024
• 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