MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS3 DRAINAGE SYSTEM; CSF DRAIN SYS/CRANIAL ACCESS

Catalog Number	821730C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	03/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a leak was noticed on eds3 drainage system (id 821730c) at the level of valve (sampling tap) during the change of bandage.The drainage system was implanted on (b)(6) 2024 due an arteriovenous malformation.The anti-reflux valve was replaced, then the entire system was replaced as it was still leaking.
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
Eds3 drainage system was returned for evaluation: dhr - no anomalies.Failure analysis - the eds was visually inspected; cracks and stress marks were noted in the system stopcock connector.The complaint is confirmed.Root cause - the root cause for the issue reported by the customer is due to over tightening, as noted in the ifu finger tightening when connecting devices.

• Brand Name: EDS3 DRAINAGE SYSTEM
• Common Device Name: CSF DRAIN SYS/CRANIAL ACCESS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18966526
• Report Number: 3013886523-2024-00081
• Device Sequence Number: 6571369
• Product Code: JXG
• UDI-Device Identifier: 10381780521020
• UDI-Public: (01)10381780521020(17)280831(10)7282443
• Combination Product (Y/N): N
• PMA/510(K) Number: K172537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 821730C
• Device Lot Number: 7282443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 03/24/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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 Age: 19 YR
• Patient Sex: Male