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

Catalog Number	INS8400
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
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
A facility reported that the accudrain without the anti-reflux valve (ins8400) was placed on (b)(6) 2024 and was found to be clogged on (b)(6) 2024.As a result, the accudrain was resolved with scanner and rinse, and the device remains implanted.No information has been provided on patient outcome.
Additional Manufacturer Narrative
Accudrain without the anti-reflux valve (ins8400) was not returned, and no photo was provided that could clarify the cause of the reported blockage.Therefore, a verification cannot be made to determine a possible root cause.It is noted that the device was implanted on (b)(6) 2024 and was reported clogged on (b)(6) 2024; therefore, the unit worked for 4 consecutive days without any issues.It was also reported that the neurosurgeon associate was able to unclog the device and that it was still in use on (b)(6) 2024 (removal date is unknown).This supports that the reported condition is not related to a device malfunction.In addition, the customer reported three (3) separate complaints (this one included) related to clogged units involving two (2) different lots: (7403915 and 7403931); however, there are no other complaints for the reported lots aside from these ones.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.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.
Additional Manufacturer Narrative
The accudrain without the anti-reflux valve (ins8400) was subsequently returned: failure analysis - the unit¿s lot number: (7403931) confirms the lot number reported by the customer.The unit was visually inspected, and it was noticed that the unit had been cut just under the patient-line stopcock.Also, there was a blue stripped line attached to the zero-reference stopcock.Water was passed through the blue stripped line and into the system through the zero-reference stopcock and water flowed freely: no occlusion noticed.Also, water was passed through the patient line stopcock and no occlusion was detected.Therefore, the complaint is unconfirmed for occlusion.Root cause - it is noted that the device was implanted on (b)(6) 2024 and was reported clogged on (b)(6) 2024; therefore, the unit worked for 4 consecutive days without any issues.It was also reported that the neurosurgeon associate was able to unclog the device and that it was still in use on (b)(6) 2024 (removal date is unknown).This supports that the reported condition is not related to a device malfunction.In addition, the customer reported three (3) separate complaints (this one included) related to clogged units involving two (2) different lots: (7403915 and 7403931); however, there are no other complaints for the reported lots aside from these ones.Based on the foregoing, a probable root cause has been identified in the product ifu¿s ¿complications¿ section as follows: ¿obstruction, partial obstruction, or irregular flow, may occur.Causes may include (but not limited to) obstruction by particulate matter (blood clots, fibrin, brain fragments), or mal-positioning of the ventricular catheter." no further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20803064
• Report Number: 2648988-2024-00045
• Device Sequence Number: 15936316
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2025

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: 05/31/2026
• Device Catalogue Number: INS8400
• Device Lot Number: 7403931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 01/24/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/21/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown