MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BEVD 1.9MM CAT SET; BACTISEAL EVD CATHETERS

Catalog Number	821749
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a bactiseal catheter (id 821749) was leaking a minimal amount of cerebrospinal fluid (csf) at the side wall of the end portion of the catheter.The event happened during implantation (before implantation site closure).The procedure was completed with a replacement product available.No adverse consequences reported, and the event did not lead to surgical delay.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 the bactiseal catheter (id 821749) was returned for evaluation.Device history record (dhr) - the product code 821749 with lot 7365500 conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected.The leak test was performed; no leaks were noted.The complaint could not be confirmed.Root cause analysis - no root cause for the issue reported by the customer could not be determined as no defects could be found with the catheter.A possible root cause for the reported issue could be due to a sharp or pointed object coming into contact with the catheter, as noted in the ifu silicone has a low cut/tear resistance.

• Brand Name: CODMAN BEVD 1.9MM CAT SET
• Common Device Name: BACTISEAL EVD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21857955
• Report Number: 3013886523-2025-00076
• Device Sequence Number: 17320725
• Product Code: JXG
• UDI-Device Identifier: 10381780518440
• UDI-Public: (01)10381780518440(10)7365500(17)250228
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 821749
• Device Lot Number: 7365500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian