MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
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 physician reported a peritoneal catheter (id (b)(6)) and a was implanted due to secondary normal pressure hydrocephalus (snph) on an unknown date.The catheter was used in with a silascon lumbar catheter (manufactured by kaneka; product code: 702-jj) and a certas valve (id (b)(6)).A subcutaneous leak was observed during injection of a contrast agent.Due to suspicion of a shunt malfunction, the entire shunt system was removed.According to information provided, it is unknown if the patient experienced any signs or symptoms related to the leak.It is also unknown where the leakage specifically occurred.
Additional Manufacturer Narrative
Updated fields: d8, d9, g6, h1, h2, h3, h8, h11.The bactiseal peritoneal catheter (823074) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defect was noted.The catheter was irrigated, no occlusion noted.The complaint could not be confirmed.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.Additional information received form reporter: "it was confirmed that there was no issue with the product.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h11.Corrected fields: b1, h1, h6/f10.Additional information received: "it was confirmed that there was no issue with the product.".

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Common Device Name: BACTISEAL
• 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: 24034753
• Report Number: 3013886523-2025-00348
• Device Sequence Number: 9058165
• Product Code: JXG
• UDI-Device Identifier: 10381780515630
• UDI-Public: 10381780515630
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 823074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• Supplement Date Received by Manufacturer: 02/09/2026; 03/05/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/27/2026; 03/30/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CERTAS VALVE (ID 828804); SILASCON® LUMBAR CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown