MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE W SG 823832; INTERNAL CSF DRAINAGE

Catalog Number	823832
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
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 facility reported a hakim valve (id 823832) was leaking cerebrospinal fluid (csf) during procedure before implantation site closure.The event did not led to surgical delay.The procedure was completed with a replacement product available.The patient is currently in stable condition with no complications reported.
Additional Manufacturer Narrative
Updated fields, d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823832) was returned for evaluation.Device history review: the product code 82-3832 with lot 7392789 conformed to specifications when released to stock.Failure analysis: the position of the cam when the valve was received was at setting 160 mmh2o.The valve was visually inspected; the surface of the housing on the siphon guard was cut and another cut on the casing was noted (between the needle chamber and the cam mechanism).The valve passed the programming test.The valve was not flushed as the valve was torn.The valve failed the leak test.The valve was examined under microscope at appropriate magnification: 2 cut/tears in the silicone housing were noted.Root cause analysis: the root cause for csf leaking reported by the customer, is due to the tear in the housing.The root cause for the ¿tear mark¿ could be due a sharp or pointed object coming into contact with the valve in view of the tear mark on the needle chamber.As noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE W SG 823832
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 24129708
• Report Number: 3013886523-2026-00009
• Device Sequence Number: 18738866
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)290430(10)7392789
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 7392793
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian