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

Model Number	INS8400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
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 during the transfer from neurosurgical icu to neurosurgery operating room, csf was found in the collection bag of the accudrain without the anti-reflux valve system (ins8400).The liquid was in contact with the anti-bacterial filter at the air intake.The unit could not be used longer, and the drainage could not be done correctly.This incident exposed the patient to risk of acute hydrocephalus, intracranial hypertension, possible brain damages or death.The patient underwent another surgery for implant of another drainage set.
Additional Manufacturer Narrative
Accudrain (ins8400) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.Failure analysis - the reported condition could apply to any device since the reported condition is the current product design, not a defect.The complaint was originally written in french, and it appears to be a mistranslation when stating that ¿csf was found in the collection bag." ¿dispositif de recueil¿ is the ¿collection device¿: in this case the burette, not the drainage bag.Therefore, the complaint should read as follows: ¿on (b)(6) 2022, during the transfer from neurosurgical icu to neurosurgery operating room, csf was found in the collection device of ventricular drainage system.The liquid was in contact with the anti-bacterial filter at the air intake.The unit could not be used longer.The drainage could not be done correctly.¿ as per complaint description, the customer¿s concern is that the burette¿s hydrophobic filter gets wet with csf during a patient¿s transfer.The described process is that, while the burette is holding an unknown amount of csf, the device it is laid down to transfer the patient.This practice is not considered appropriate because the unit must be always maintained in a vertical position and whenever it is not required to have the system in ¿full use¿, the panel-mount (or zero-reference) stopcock must be closed, and the burette should be emptied into the drain bag.Then the burette¿s stopcock should be closed to prevent retrograde flow (back into the burette).This would eliminate the risk of wetting the antimicrobial hydrophobic vent (filter).Product ifu also clarifies that if necessary to remove the system form the vertical secured position (from the iv-pole), to orient the burette side-up and always with an empty burette.As per product¿s instructions for use (ifu), the product¿s set up is done in a vertical position and to follow the following procedure (in the to transport patient section): ¿if it is necessary to transport a patient while system is in full use, the system should remain vertical and correctly aligned with the patient for desired pressure level and drainage.If this is not possible, the graduated burette should be emptied into the drainage bag.The burette stopcock should then be temporarily closed to prevent retrograde flow back into the burette.The panel mount stopcock should be oriented to temporarily stop flow from the patient to the burette.Caution: if it becomes necessary to remove the system from the vertical secured position, orient the system burette side up and support the weight of the drainage bag when lifting or during movement.¿ it is important to emphasize that during patient transport, the panel-mount stopcock must be closed if the device will not be maintained at the preestablished drainage alignment (as in this case).This will prevent either a csf retrograde flow or a csf over-drainage.Root cause - based on the foregoing failure analysis, although not an ideal scenario, even if the ¿anti-bacterial filter¿ gets wet with csf, this does not render the device useless; as per product¿s ifu precautions section: ¿while the filter is hydrophobic, some manipulation may be required to reestablish drainage after repeated prolonged contact with csf.¿ therefore, the root cause for the reported event is user related.Handling of the accudrain should be done according to the ifu.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.

• 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
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15910984
• Report Number: 2648988-2022-00025
• Device Sequence Number: 14070635
• 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
• Report Date (Section B): 12/16/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: INS8400
• Device Catalogue Number: INS8400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 12/16/2022
• 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