MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS DRAINAGE SYS NO V CATH; CSF DRAIN SYS/CRANIAL ACCESS

Catalog Number	821731C
Medical Device Problem Code	Leak/Splash (1354)
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 an eds drainage system leaked at the stopcock nearest to the chamber.Comments from customer : "although i appreciate the stopcock when closed to the patient can redirect csf out if the bung is loose ¿ the nurses reported csf leaking despite the bung being secure and although i saw the system when it was removed from the patient so no csf pressure i also witnessed csf leaking from the stopcock with the bung secure.I wondered if there was a crack in the system or ill-fitting bung.".
Additional Manufacturer Narrative
Additional information received: - the system had to be changed on the patient - there were no consequences for the patient - evd placed due to tumor resection - patient is 3 years old.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Eds drainage system was returned for evaluation: failure analysis - the eds was visually inspected and confirmed cracks in the stopcock nearest the chamber.The eds set up per ifu.The device was leak tested, leakage for the stopcock nearest to the chamber.The current quality inspection for these assemblies is established to 100% test for leaks and blockage.Complaint confirmed.The root cause for the issue reported by the customer is due to over tightening when connecting devices, as noted in the ifu finger tighten only.
Event or Problem Description
N/a.

• Brand Name: EDS DRAINAGE SYS NO V CATH
• 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 ; 6099362319
• MDR Report Key: 17780644
• Report Number: 3013886523-2023-00328
• Device Sequence Number: 15097124
• Product Code: JXG
• UDI-Device Identifier: 10381780518327
• UDI-Public: 10381780518327
• 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
• Report Date (Section B): 12/08/2023

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: 821731C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 09/27/2023; 11/16/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/20/2023; 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 3 YR
• Patient Sex: Unknown