MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS3 CLEAR VENT CATH; STANDARD EVD CATHETERS

Catalog Number	821735
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported a neurosurgery resident was flushing patient's evd (codman eds 3 csf external drainage system - id 821735).The resident and the bedside rn noticed the codman tubing had a leak in it.There was no drainage/ leakage noticed prior to this incident and no drainage noted on sheets.A new codman eds 3 csf external drainage system was placed.No additional information has been received after several attempts.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields.Additional information provided: the eds 3 csf external drainage system was replaced; however, the ventricular catheter (id 821735) was not replaced.The event led to less than 30 minutes surgical delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h3, h6, h11.The evd (codman eds 3 csf external drainage system - id (b)(6)) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to a problem in the connection between the patient line and the eds system.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: EDS3 CLEAR VENT CATH
• Common Device Name: STANDARD 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: 22097074
• Report Number: 3013886523-2025-00124
• Device Sequence Number: 6947857
• Product Code: JXG
• UDI-Device Identifier: 10381780518372
• UDI-Public: 10381780518372
• Combination Product (Y/N): N
• PMA/510(K) Number: K061568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2025

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 Catalogue Number: 821735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 07/14/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/26/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian