MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EVD 20 ML; EXTERNAL CSF DRAINAGE

Catalog Number	INS9020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2025
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 an incident occurred in their icu where a component in the evd kit (ins9020 limitorr volume limiting) broke while in use.No additional information has been provided.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The limitorr volume limiting evd (ins9020) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomaly was observed during its manufacturing process that could be related to the reported condition.Failure analysis - the visual inspection of the returned product shows that a segment of the patient-line (proximal to patient), from the patient-line¿s stopcock onward, was missing.It is assumed that when the customer states that the ¿evd kit broke while in use¿ it is meant that the tubing detached from the patient-line¿s stopcock.From the part that was returned it was observed that the tubing was completely inserted into the stopcock connector.This was done by comparing it to the connection of the manifold stopcock found on the returned device.This stopcock is the same part number as the one missing.Also, it was observed that there were adhesive residues on the tubing in the area that is inserted into the stopcock¿s connecting area.Therefore, the evidence supports that the tubing to stopcock assembly was correctly performed as it was evidenced from the returned unit.Root cause - the complaint is confirmed via the inspection.There is not much information about details surrounding the event except that it broke while in use.It is unknown the amount of time the device was in use prior to the disconnection; also, it is unknown what activities were taking place such as moving the patient, transporting, etc.It appears that the device was properly functioning until the disconnection.Based on the device¿s evaluation that confirmed that the device was correctly assembled, and that the device was in use, the root cause is likely related to some fortuitous event at the user¿s facility (got tangled, pulled, etc.) while the product was in use.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: LIMITORR VOLUME LIMITING EVD 20 ML
• Common Device Name: EXTERNAL CSF DRAINAGE
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24208967
• Report Number: 2648988-2026-00001
• Device Sequence Number: 5483765
• Product Code: JXG
• UDI-Device Identifier: 10381780071105
• UDI-Public: 10381780071105
• Combination Product (Y/N): N
• PMA/510(K) Number: K191684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: INS9020
• Device Lot Number: 7443433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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 Sex: Unknown