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

Catalog Number	INS8401
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 2 of 2 reports linked to mfg report number 2648988-2024-00041 for the accudrain ins8401 because the customer is not sure which device was in use: a facility reported that external ventricular drain (accudrain ins8401) 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.
Additional Manufacturer Narrative
The accudrain with anti-reflux valve (ins8401) was returned for evaluation: device history record (dhr) review - the dhr was reviewed and no anomaly was reported during the manufacturing process that could be related to the reported condition.Failure analysis - upon visual inspection, it was found that the unit lot number is 7348743 and the catalog number was confirmed to be an ins8401 (accudrain with anti-reflux valve).Further inspection showed that the product¿s general appearance was good: no detached connections or obvious broken/cracked parts such as stopcocks.Since the complaint information clarified that a leak was observed ¿just ahead of the burette¿, special attention was provided to this area.It was observed that the bushing tubing that connects the green line tubing from the patient line to the burette top port was partially torn.Therefore, the reported condition was confirmed.Root cause - the most probable cause for the tube breakage is related to the operation involving the tube expander during product assembly.This tubing connection is assembled using a tube expander to insert the burette¿s top port into the bushing tubing.When interviewed, the operators showed knowledge in the operation and explained that the partial tear could be caused during the tube expansion.Awareness training was provided to all personnel of the external drainage systems (eds) assembly line to ensure that they know about the reported condition and investigation findings.This type of event is monitored and trended for recurrence; no other complaints have been issued related to the reported condition.No further action is required at the moment.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: 20758992
• Report Number: 2648988-2024-00042
• Device Sequence Number: 13077353
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: INS8401
• Device Lot Number: 7348743
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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 Age: 54 YR
• Patient Sex: Female