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

Catalog Number INS9020

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The first report of two involving the same product from the same facility.Ins9020 limitorr volume limiting evd 20ml was reported that the glue got disconnected from the line past the patient iv port.The resident reported that "they keep them in much longer than 5 days so he said the glue probably would be saturated at that time.I asked him how many days and he wouldn't say but did say longer than five days." additional information has been requested.

Manufacturer Narrative

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

Manufacturer Narrative

Integra has completed their internal investigation on 06/10/2015.Method: eval of actual device; review of device history records; review of complaint history.Results: the clear pvc tubing most proximal to the csf access port was detached from the stopcock.Upon close examination, traces of adhesive were noticed in one section of the clear pvc tubing and stopcock.No other traces of adhesive were noticed in the remaining sections of the tubing or stopcock.Device history record (dhr) of the finish good lot #1141301 for complaint pr# (b)(4) was reviewed in order to detect any anomalies that could have occurred during the inspection and manufacturing process of the product which could have contributed and/or be related with the reported condition (pt line tubing detachment) being investigated.The manufacturing date of fg lot # 1141301 is 2014-04 and the expiration date is 2016-03.The fg lot #1141301 was released for distribution on 06/19/2014 in compliance with the product specifications and integra requirements.No anomaly or discrepancy was reported during the manufacture of the fg lot that could be related to the reported condition.A review of complaint system since 2013 to present, a total of (b)(4) complaints (including these) related to the reported condition (pt line tubing detachments) for limitorr family catalogs, (b)(4).Based on the info provided by the customer regarding pt line tubing detachments, a summary of the product's instructions for use (ifu) is provided below for further eval of the complaint."precautions: all luer connections must be checked during priming of the system and prior to connecting to the pt.Ensure that all connections are secure and leak free." conclusion: based on the description of the event reported and product failure analysis, the reported condition (pt line tubing detachment) was confirmed.Upon eval of the unit, traces of adhesive were noticed in one section of the clear pvc tubing and stopcock.No other traces of adhesive were noticed in the remaining sections of the tubing or stopcock.Therefore, based on failure analysis of returned unit, a potential root cause may be attributable to the bonding method used for the assembly of the clear pvc tubing and stopcock.

• Brand Name: LIMITORR VOLUME LIMITING EVD 20 ML
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; anasco PR 00610
• Manufacturer Contact: linda serentino ; 315 enterprise drive; 6099365560
• MDR Report Key: 4814510
• MDR Text Key: 5928804
• Report Number: 2648988-2015-00051
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS9020
• Device Lot Number: 1141301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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