MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN; N/A

Catalog Number XXX-ACCUDRAIN

Device Problem Break (1069)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.No lot number was provided; therefore, no dhr review is possible.Three (3) photos were provided, each attributed to a different complaint - mfg report numbers: 2648988-2018-00047 and 2648988-2018-00049, but they are of the same device.Therefore, only one complaint (mfg report number: 2648988-2018-00047) will be confirmed based on the photos provided.A leak was reported from the patient line stopcock (proximal to the patient).Patient line stopcock is component p/n 200407-001 of which each accudrain unit has two (2) of them (patient line, and zero reference stopcocks).Only the patient line stopcock was reported as leaking.All stopcocks are visually inspected prior assembly, and each assembled patient line is leak tested during the manufacturing process to prevent this type of defects.The complaints explain that the devices were in use for several weeks prior to breakage (32, 28, and 17 days respectively).They also state that one of the patients was also receiving ¿intrathecal abx¿ and was clamped and unclamped multiple times a day.In another patient the drain system fell off the pole and certainly could have damaged the line.Also, eeg removal spray was used, apparently in at least two of them.This type of spray may have chemicals that could make the stopcock material brittle.No further evaluation is possible at this moment.Linked to mfg number: 2648988-2018-00047 and 2648988-2018-00049.

Event Description

This is 2 of 3 reports.This is in regards to the second patient.An account manager reported in behalf of customer that the xxx-accudrain (accudrain external csf drainage system) had leakage of fluid due to a crack below the white stopcock.It was also mentioned that the facility had couple of such events in the past.Additional information received on (b)(6) 2018 stating that the three patients all had the external ventricular drains (evds) for roughly one month.This patient ((b)(6)) was using the evd from (b)(6) 2018 to (b)(6) 2018, totaling 28 days.It was also reported that the electroencephalography (eeg) was used from (b)(6) 2018 to (b)(6) 2018.The customer believed that the leak was noticed prior to the removal of the eeg.All three units were discarded by the customer.It was reported however that the user facility performed an experiment to see if the collodion spray affected the strength of the plastic.It did conclude that the spray did weaken the rigid plastic parts making them more brittle.

• Brand Name: ACCUDRAIN
• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8054466
• MDR Text Key: 126649004
• Report Number: 2648988-2018-00048
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-ACCUDRAIN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• 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