MAUDE Adverse Event Report: Integra NeuroSciences PR AccuDrain with Anti-Reflux Valve; External CSF Drainage

Catalog Number	INS8401
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
N/a.
Event or Problem Description
A facility reported that the accudrain device (catlog# unknown) was used on a patient to drain csf, and the port closest to the head with the yellow cap was leaking; when they attempted to remove the cap, it cracked off.It was reported that there was no injury to the patient, but infection was noted.Additional information regarding the type of infection and any required intervention has been requested.
Additional Manufacturer Narrative
Updated fields: d1, d2a, d4, d9, g3, g6, h2, h3, h4, h6, h11.The accudrain with anti-reflux valve (ins8401) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities that could be associated with the reported condition.Failure analysis - a segment of the patient line proximal to the patient, a red cap, a yellow cap, and a green (non-integra) cap were returned for evaluation.Because the leak was reported at the "port closest to the head with the yellow cap," the yellow cap was visually inspected and no cracks or defects were observed.However, evaluation of the patient-line stopcock revealed cracks on the side and bottom of the stopcock body.Additionally, the port to which the yellow cap had been attached was found broken off and remained attached to the yellow cap.The stopcock also exhibited a whitish, opaque appearance, which is characteristic of exposure to an incompatible chemical substance.Based on the observed condition, the stopcock was likely exposed to collodion remover and/or acetone.Root cause - the complaint was confirmed.The most probable cause of the reported leak was cracking of the stopcock body.Evidence observed on the device confirms that the stopcock came in contact with an incompatible chemical substance.It is likely that this chemical is the collodion remover used to remove the eeg electrodes from the patient¿s head.This is also supported by the report stating that the leak was observed at the ¿port closest to the head¿.The product ifu already addresses the risk of incompatible substances coming in contact with plastic components.As per ifu precautions, ¿contact with collodion remover, acetone and/or any other incompatible substances with product material may affect the integrity of the device, causing cracks and potential leaks on plastic components.¿ a causal relationship between the reported leak and the reported infection could not be established.Furthermore, it is unlikely that the infection manifested on the same day as the leak event, as bacterial growth and the development of infection generally require time.The ifu addresses infection-related risks associated with cerebrospinal fluid drainage systems and states: ¿the principal complications associated with cerebrospinal fluid drainage are infection, obstruction, or intracranial hypotension/ hypertension.The presence of a foreign body (i.E.The catheter system) may trigger infection or adverse reaction.Infection is a common and serious complication of a drainage system and is most frequently caused by skin contaminants.The incidence of these infections can be reduced by using aseptic technique.Risk of infection or other complications may be reduced by following hospital protocol for duration of use.Septicemia can result from infections anywhere in the body and may develop with few or no symptoms.¿ no further investigation is required based on the acceptability of the risk and the absence of adverse trends.This issue will continue to be monitored through the complaint trending process.At this time, the complaint is considered closed.
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.

• Brand Name: AccuDrain with Anti-Reflux Valve
• 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 ; +1(609)936-2319
• MDR Report Key: 50161280
• Report Number: 2648988-2026-00024
• Device Sequence Number: 18785834
• Product Code: JXG
• UDI-Device Identifier: 10381780023883
• UDI-Public: 10381780023883
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: INS8401
• Device Lot Number: 7639341
• Date Returned to Manufacturer: 08/26/2026
• 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: 09/03/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2026
• 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: 70 YR
• Patient Sex: Female
• Patient Race: Black Or African American