MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITH ANTI-REFLUX VALVE; EXTERNAL CSF DRAINAGE

Catalog Number	INS8401
Medical Device Problem Codes	Fracture (1260); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
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
Mw5184806 was received with the following information: "plastic part of external ventricular drain broke and device fell to ground." additional information was subsequently received as follows: 1.Type of event selected in the medwatch is "serious injury".Provide details of the serious injury.Answer: this is incorrect.There was no injury.I am sure the event type checked was potentially harmful event.There was no harm to the patient.2.Please advise the type of procedure for which accudrain was used.Answer: csf drainage after subdural bleed.3.Was there csf leakage during the incident? answer: no 4.If csf leaked, how much was it (if an exact amount cannot be provided, please provide an approximate: small amount, moderate, etc.) answer: n/a 5.After accudrain broke and fell, was it replaced with another device? answer: yes, another accudrain was attached.6.Was any medical intervention performed as a result of this incident? answer: no 7.Was there significant delay to treatment? if yes, how long was the delay in minutes? no answer given 8.Did the patient present with clinical signs and symptoms, and if so, what were they? answer: from this event- none.From initial injury- change in mental status after fall 9.Please provide patient outcome- answer: no change in outcome related to this device.10.Please also provide any additional information relevant to the incident not specifically asked.Answer: staff asked if there is a study of outcomes regarding care of the patient with evd if the drainage bag is emptied vs changing of the entire system? our policy is to change the bag and tubing when 3/4 full.

• 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 ; 6099362319
• MDR Report Key: 24984907
• Report Number: 2648988-2026-00013
• Device Sequence Number: 9480851
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: INS8401
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Race: White