MAUDE Adverse Event Report: Integra LifeSciences Switzerland SAR 14G TOUHY NEEDLE; Internal CSF Drainage

Catalog Number	990003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction

• Brand Name: 14G TOUHY NEEDLE
• Common Device Name: Internal CSF Drainage
• Manufacturer (Section D): Integra LifeSciences Switzerland SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): Integra LifeSciences Switzerland SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50240564
• Report Number: 3013886523-2026-00202
• Device Sequence Number: 10292467
• Product Code: JXG
• UDI-Device Identifier: 10381780034407
• UDI-Public: 10381780034407
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 990003
• 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: 07/23/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 10/01/2026
• 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
• Patient Age: 89 YR
• Patient Sex: Female