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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported an external drainage system (id 821731c) was leaking from the buretrol while being used on a patient.No patient injury reported, and the event did not lead to surgical delay.
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
The external drainage (id 821731c) was returned for evaluation.Failure analysis - the eds was set up per instruction for use (ifu).The eds was flushed; 2 leaks were noted from 2 of the connectors.The complaint was confirmed.Root cause analysis - the root cause for the issue reported by the customer could be due to using atypical force when connecting devices.As noted in the instruction for use (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 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: 19731509
• Report Number: 3013886523-2024-00200
• Device Sequence Number: 8274536
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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
• Device Lot Number: 670869
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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