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

Catalog Number INS8400

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2017

Event Type  malfunction  

Event Description

Two accudrains (ins8400) were used as bilateral subdural drains post craniotomy for bilateral subdural evacuation.These drains were connected to a trauma catheter placed in the subdural space and leveled at the eam (external auditory meatus) at (-)20cm h2o.The drain on the right was noticed to be pulling in air which was described by the acting unit director to appear to be potentially coming from the burette.He stated that when he raised the drain even slightly the air moved rapidly towards the patient.The drain was removed immediately and not replaced.The other drain on the left did not seem to be having the same issue but was taken out soon after.There was no patient injury reported.The drain on the left was reported to be from a different lot number but was not kept so the lot number was not known.All drains with the lot number 1170009 were pulled from the shelves and placed in a locked storage.Linked to mfg.Report number 2648988-2017-00022.

Manufacturer Narrative

Investigation completed 07/21/2017.Four devices were received on 7/12/17.The devices received were of lot 1170009.The devices were not in their original packages; one of them still had a catheter attached to it; also, two (2) loose (not attached to any of the devices) transducers were included in the package.The devices were inspected and as stated on the medwatch no cracks or any other observable defect was noticed.The systems were purged with water to see if there were any leaks: none were found.Stopcocks were aligned leaving an open path all the way to the patient line¿s stopcock (proximal) to see if water would backflow in the system: no air was drawn into the system.The air would only get in the system if one (1) of the two (2) stopcocks (patient line or zero reference) was opened.In that case air, would get into the system from the chamber as described in the medwatch.The application ¿bilateral subdural evacuation¿ is an off-label application of these devices.According to the complaint, the device was ¿leveled at the eam at (-)20cm h2o¿.The pressure scale provided with the device is from -5 to +30cm h2o; therefore, not totally clear how it was set to -20 cm h2o.As per ifu the indicated use is in the ¿ventricles of the brain¿ or ¿lumbar subarachnoid space¿: ¿indications: draining and monitoring of cerebrospinal fluid (csf) flow from the ventricles of the brain or lumbar subarachnoid space is indicated in selected patients to: ¿ reduce intracranial pressure (icp).¿ monitor intracranial pressure (icp).¿ monitor cerebrospinal fluid (csf).¿ provide temporary csf drainage.¿ no unusual event related to the reported failure was noticed during the lot records review.The lot complied with all release criteria including functional tests such as leakage, occlusion, and pull tests.Nothing abnormal was noticed in the returned samples failure analysis.Thus far, only the (b)(6) hospital has complained regarding this issue.(b)(4) and no complaint has been reported against it from any of the other facilities.Ins-8401 and ins-8400 are visually almost identical except that ins-8401 has an anti-reflux valve on the patient line which prevents csf return when there are changes in the patient¿s condition (for example: icp changes, device height, etc.¿ in this case the complaint description mentions that ¿when he raised the drain even slightly the air moved rapidly towards the patient.¿).Thus, it may be concluded that personnel may have not been completely familiarized with the device and that it may behave differently to ins-8401.The customer did not report any leaks in the system and none was observed during the verification of the returned samples.Therefore, it seems that the system behaved as it normally does, but not as the customer expected.This most likely explains why only the ins-8400 units (lot 1170009) seemed to cause the situation.

• Brand Name: ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE
• Type of Device: 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6697750
• MDR Text Key: 79818467
• Report Number: 2648988-2017-00023
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS8400
• Device Lot Number: 1170009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR