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

Catalog Number INS9020

Device Problems Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017); Component Missing (2306); Connection Problem (2900)

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

Event Type  malfunction  

Event Description

This is the first of 2 reports (similar product problems, similar products, different product ids, different incidents, different patients).This report is in regards to the ins9020.Linked to mfr report 2648988-2014-00058.The drain has been placed in a procedural area of the hospital where the staff was not aware of the proper use of the limitorr.As a result, the drain was connected to the patient and transported to the nursing units without being mounted onto the evaluation pole mount.More importantly, the white plastic piece necessary to do so was thrown away and was not attached to the drain.There was no patient injury and no delay in surgery.Additional information received from the customer on (b)(6) 2014: the customer did not have the exact details about the incident as it was about 3 weeks ago.It was not a device failure, but operator failure.The physician setting up the drain was not aware of the importance of the small mounting piece and threw it away.The operating room secured the limitorr to the black integra pole.It functioned fine but it did create mobilization barriers as the whole device had to stay on the iv pole for the patient to ambulate to the bathroom.The integra sales representative brought the customer a mounting piece the next day.

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

• 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: 4268040
• MDR Text Key: 5297288
• Report Number: 2648988-2014-00057
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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