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	Insufficient Information (4580)
Date of Event	01/14/2025
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 that the above luer lock of the external drainage system (id (b)(6)) was broken, and cerebrospinal fluid (csf) was leaking onto the floor while emptying the collection reservoir of the external ventricular drain (evd).All other connections remained intact.Due to the location of the break, the entire evd system needed to be replaced, not just the collection bag.The two broken sections were secured with waterproof tape to maintain as much sterility as possible.The drain was removed at the bedside, and the site was sutured closed.The tip of the catheter and csf were sent for culture, and while awaiting results, the patient received three days of intravenous vancomycin and fluconazole.The cultures returned positive for contamination.A facility reported: "when emptying the collection reservoir of the external ventricular drain (evd) of 68-year-old patient, cerebrospinal fluid (csf) noted to be leaking on the floor.On closer inspection, the evd was noted to be broken above the luer lock where the bag can be changed.All other connections remained intact.Due to the placement of the break, the entire evd system would need to be replaced (not just the collection bag).The two broken sections were secured with waterproof tape to attempt to keep the system as sterile as possible.The drain was removed at the bedside and the site sutured closed.The tip of the catheter and csf were sent for culture.While awaiting results, patient received three days of intravenous vancomycin and fluconazole; cultures returned positive for contamination.".
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The external drainage system (id (b)(6)) was not returned for evaluation as the product is not available for return as per customer and 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, the possible root cause for the issue reported by the customer, could be due to human misuse.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.A corrective and preventative action (capa) was initiated to investigate this issue.
Event or Problem Description
N/a.

• 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 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: 21721035
• Report Number: 3013886523-2025-00059
• Device Sequence Number: 9492107
• Product Code: JXG
• UDI-Device Identifier: 10381780521020
• UDI-Public: 10381780521020
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 821730C
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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 Age: 68 YR
• Patient Sex: Unknown