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	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
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 changing the collection bags of an external drainage system (eds) (id 821731c) caused damage or the inability to use the current connections.On (b)(6) 2024, ventricular drainage of cerebrospinal fluid (csf) was performed using the eds.The patient was taken to the operative room to replace the eds.The event happened 4 times.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11 corrected fields: b1, h1, h6/f10.The external drainage system (eds) (id 821731c) was returned for evaluation.Failure analysis - the connector for the collection bag was visually inspected and the connector has been broken off.The complaint is confirmed.Root cause analysis - the root cause for the issue reported by the customer could be due to using a typical force when connecting the collection bag.As noted in the ifu, finger tighten only.Additional information received: "anesthesia was not required.They went to a theatre (operative room) to ensure a sterile environment but left the ventricular drainage catheter insitu".
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 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: 19415007
• Report Number: 3013886523-2024-00158
• Device Sequence Number: 16947155
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 08/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown