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

Catalog Number	INS8401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the accudrain with anti-reflux valve (ins8401) broke proximal to the patient near the stopcock.The drain disconnected and fell apart at the patient connection.There was no patient injury or delay in treatment reported.
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
N/a.
Additional Manufacturer Narrative
Updated fields: 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 no anomalies were observed that could be related to the reported condition.Failure analysis - upon visual inspection of the returned device, it was noticed that the bottom part of the patient line was not returned with the unit.The patient-line stopcock was broken and about half of it was missing including the white plug.It was observed that the remaining part of the stopcock had a whitish and opaque appearance; this appearance suggests that the stopcock was exposed to an unknown substance.The device has two (2) stopcocks , and the other stopcock (zero-reference) was in good condition: good general appearance, clear (non-whitish/opaque), and no cracks were observed.Root cause - based on the returned unit¿s stopcock appearance, the root cause for the breakage is related to patient-line stopcock coming in contact with an incompatible substance (e.G., eeg adhesive removing solvent).The product¿s ifu has the following warning: ¿contact with collodion remover, acetone and/or any other incompatible substances with the product material may affect the integrity of the device, causing cracks and potential leaks on plastic components.¿ 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.

• 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: 20204848
• Report Number: 2648988-2024-00033
• Device Sequence Number: 12482495
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 02/28/2026
• Device Catalogue Number: INS8401
• Device Lot Number: 7358695
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2024
• 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 Sex: Unknown