MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITH ANTI-REFLUX VALVE; N/A

Catalog Number	INS8401
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2025
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
Medwatch report# (mw5177375) has been received with the following information: "pt had an integra lumbar drain placed on (b)(6) 2025.On (b)(6) 2025, the lumbar drain was noted to beleaking.Upon further inspection, the lumbar drain had a pin hole in the tubing.The lumbar drain was removed." additional information has been requested.
Additional Manufacturer Narrative
The accudrain (ins8401) with anti-reflux valve was not returned for evaluation and no photos showing the reported conditions were provided.Device history record (dhr) review - lot number information was provided; therefore, the dhr was reviewed and met all in-process inspections and testing requirements as specified, including a leak test performed to each manufactured unit.The leak test is performed using a calibrated instrument that measures pressure decay in a specified amount of time.Failure analysis - based on the information provided, even though the external drainage system (accudrain) was reported in the medwatch report, the description states that the pin hole was in the ¿lumbar drain¿ tubing which may be referring to the catheter itself.Potential root cause - a root cause determination is not possible at this moment since the unit was not returned and no photos were made available for evaluation.However, since each unit is tested for leaks, a possible cause found in the device fmea is that the tubing or component was broken during shipping.No corrective and preventive action (capa) has been issued related to the reported condition in the last two (2) years, and no capa escalation or additional actions are deemed necessary at this moment.No complaint trend signal has been identified for the reported condition.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.
Event or Problem Description
N/a.

• Brand Name: ACCUDRAIN WITH ANTI-REFLUX VALVE
• Common Device Name: N/A
• 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: 23661521
• Report Number: 2648988-2025-00047
• Device Sequence Number: 10215863
• Product Code: JXG
• UDI-Device Identifier: 10381780023883
• UDI-Public: 10381780023883
• Combination Product (Y/N): N
• PMA/510(K) Number: K042825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: INS8401
• Device Lot Number: 7564324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: White