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

Model Number	INS8401
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that cerebrospinal fluid (csf) was noted to be leaking from the accudrain with anti-reflux valve (ins8401) system, and a crack was found at sampling stopcock proximal to the patient.The drainage system was exchanged by the neurosurgeon, and csf drain diversion was performed with no known delay in surgery.
Additional Manufacturer Narrative
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 - the returned unit was visually inspected.Accudrain has two (2) of the same stopcocks: one (1) located at the blue panel (zero-reference stopcock) and the other at the end of the patient-line (proximal to patient).Both stopcocks were visually inspected for defects.The zero-reference stopcock was in good condition: good general appearance, clear (non-whitish/opaque), and no cracks observed.The complaint reported that a crack was found at sampling stopcock proximal to patient; this is the patient-line¿s stopcock.It was observed that the patient-line¿s stopcock had a crack on the side of its main body.Also, it was observed that the stopcock¿s appearance was whitish and opaque; this appearance suggests that the stopcock was exposed to an unknown substance.Root cause - the complaint is considered confirmed.The most probable cause for stopcock breakage is related to product contact with an incompatible substance.In a previous capa investigation, it was concluded that the root cause for accudrain¿s stopcock breakages was associated to the use of collodion remover and/or acetone (for example, when removing eeg electrodes), and this substance coming in contact with the patient-line¿s stopcock.As a result of this finding, the accudrain¿s instruction for use (ifu) was revised in june 2019 to include precaution statements to alert users to avoid product contact with collodion remover, acetone, or any other incompatible substances.No other action is required at this moment because the most probable cause of breakage is in alignment with the capa¿s findings and conclusions.
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
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16738187
• Report Number: 2648988-2023-00008
• Device Sequence Number: 6597269
• 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): 04/27/2023

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: 01/31/2024
• Device Model Number: INS8401
• Device Catalogue Number: INS8401
• Device Lot Number: 6197179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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