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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2023
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 eds external drainage system is leaking from the three way stockcock.Drainage system was replaced.
Additional Manufacturer Narrative
The eds external drainage system (id 821731c) was returned for evaluation.Failure analysis - the eds was visually inspected; cracks in the 3 way stop cock were noted.The eds was leak tested; failed leaked from the crack in the 3 way stop cock.The current quality inspection for these assemblies was established to 100% test for leaks and blockage.Root cause analysis : 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.

• 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: 18221414
• Report Number: 3013886523-2023-00423
• Device Sequence Number: 5602394
• Product Code: JXG
• UDI-Device Identifier: 10381780518327
• UDI-Public: 10381780518327
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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
• Report Date (Section B): 02/14/2024

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?: 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: 11/08/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 02/14/2024
• 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 Sex: Unknown