MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EVD 20 ML

Catalog Number INS9020

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

The drain had fallen apart.The drain was in two pieces with the float valve missing.The drain was replaced on the pt and no issues have arisen.Additional info was requested and on (b)(6) 2014, the customer provided the following: it was unk when the product problem occurred.The drain was found on (b)(6) 2014 broken.It has been in use for about a week.It was not known when and how the drain actually broke.It was reported that the drain was working consistently.However, one nurse had trouble one night getting enough cerebrospinal fluid (csf) off per hour and had "dropped it down to the floor for a period of time".The day shift registered nurse (rn) found the drain broken on the morning of (b)(6) 2014.The customer stated "my sense is that something someone did caused this drain to break but i do not know what i suspect the bed was lowered and may have been the culprit".The drain was immediately switched out.The product lot number was unk.The pt's underlying medical condition was believed to be subarachnoid hemorrhage.There was no pt harm or injury at the time of the report.Csf sample was sent.There was no surgery/treatment delay due to the product problem.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

• Brand Name: LIMITORR VOLUME LIMITING EVD 20 ML
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 3805012
• MDR Text Key: 21877912
• Report Number: 2648988-2014-00009
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS9020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR