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

Catalog Number	821730C
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
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: the white nut of an eds3 drainage system was disconnected from the pipe attached to the skin: "at 10 p.M., i arrived in the room to empty the 10 cc external lumbar drainage.The emptying was performed without any problems, the external lumbar drainage was then re-clamped, and my colleague and i repositioned the patient.As we replaced the sheet, we noticed that the white nut was disconnected from the tube attached to the skin.I immediately clamped the tube and notified the doctor, then the surgeon.The latter intervened under sterile conditions to cut a piece of the tube and reconnect the external lumbar drainage in a sterile manner.The entire procedure was performed in compliance with aseptic rules." actions taken: increased monitoring level.No additional information was provided after several attempts.
Additional Manufacturer Narrative
Correction: follow #1 was sent with us regulatory awareness date (g3) 06/27/2025.The correct us regulatory awareness date is 09/30/2025.Additional information received: date of the incident? on (b)(6) 2025.Did this incident have any consequences for the patient? if so, what were they? patient endangered (infectious).Was the system modified following the incident? or was your intervention successful? the intervention was successful, but the device was replaced the next day.How is the patient now? apparently, no impact from the device malfunction (patient very deteriorated).Is it a baby, a child, an adolescent, an adult, an elderly person? the patient was an adult.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The eds drainage system was returned for evaluation: dhr - lot 7481108 conformed to the specifications when released to stock.Failure analysis - the eds was visually inspected, no defect was noted.The eds was leak tested passed, no defect was noted.However, the catheter was cut in two parts and only one part was returned for investigation so we could not confirmed the complaint.Root cause - no root cause could be determined as the catheter was cut in two parts and only one part was returned for investigation.The possible root cause for the issue reported by the customer could be due to human misuse.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h11.Corrected fields: d9, h2, h3.

• Brand Name: EDS3 DRAINAGE SYSTEM
• Common Device Name: CSF DRAIN SYS/CRANIAL ACCESS
• 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 08540 ; 6099362319
• MDR Report Key: 21857733
• Report Number: 3013886523-2025-00079
• Device Sequence Number: 4721847
• Product Code: JXG
• UDI-Device Identifier: 10381780521020
• UDI-Public: (01)10381780521020(17)271231(10)7481108
• Combination Product (Y/N): N
• PMA/510(K) Number: K172537
• 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,Followup,Followup
• Report Date (Section B): 01/16/2026

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: 821730C
• Device Lot Number: 7481108
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 12/24/2025; 01/16/2026
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 10/17/2025; 01/16/2026; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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