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U.S. Department of Health and Human Services

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

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INTEGRA NEUROSCIENCES PR ACCUDRAIN N/A Back to Search Results
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.
 
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Brand NameACCUDRAIN
Type of DeviceN/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 Key8054466
MDR Text Key126649004
Report Number2648988-2018-00048
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K042825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-ACCUDRAIN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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