MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE; N/A

Catalog Number	INS8400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
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
This is 1 of 2 reports linked to mfg report number 2648988-2024-00042 for the accudrain ins8400 because the customer is not sure which device was in use: a facility reported that external ventricular drain (accudrain ins8400) was placed at the bedside for ivh and obstructive hydrocephalus, and shortly thereafter, blood was noted to be leaking from the device just ahead of the burette.Nursing and neurosurgery assessed the device and noted what appeared to be a crack at the connection site.The system was replaced and reconnected to the patient¿s evd without further leaking.The patient was stable at the time but subsequently died.The customer reported that the patient's demise is unrelated to the drain issue.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The accudrain (ins8400) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, device history record (dhr) could not be reviewed.The root cause of the reported issue could not be determined.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.

• Brand Name: ACCUDRAIN WITHOUT THE 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: 20763064
• Report Number: 2648988-2024-00041
• Device Sequence Number: 20972760
• Product Code: JXG
• UDI-Device Identifier: 10381780023876
• UDI-Public: 10381780023876
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: INS8400
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/08/2025
• 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: 54 YR
• Patient Sex: Female