MAUDE Adverse Event Report: Integra LifeSciences Mansfield VENT RES TR RICKHAM LG BA; Internal CSF Drainage

Catalog Number	821623
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3,,h6 h11 the catheter (id 821623) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, the possible root cause for the ¿infection,¿ reported by the customer, could be linked to the patient and hospital surroundings.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Additional information received: "the outcome of the event previously reported as recovering/resolving has been updated by the investigator to recovered/resolved on 03-jul-2026.".

• Brand Name: VENT RES TR RICKHAM LG BA
• 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 ; +1(609)936-2319
• MDR Report Key: 50175249
• Report Number: 3013886523-2026-00195
• Device Sequence Number: 8270450
• Product Code: JXG
• UDI-Device Identifier: 10381780517788
• UDI-Public: 10381780517788
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 821623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 71 LB