MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. SELECTOR STERILE TUBING KIT (10)

Catalog Number 1517079

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

The customer reported that a selector sterile tubing kit (b)(4) had leaking issues.There was pt contact; however, there was no injury involved with this complaint.

Manufacturer Narrative

The device involved in the reported incident has been received for eval.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation 06/08/2015.Results - product tubing was returned but the alleged complaint could not be reproduced and therefore was not confirmed.Dhr was not reviewed because lot number was not provided when the complaint was filed.After reviewing the complaint system, five complaints, including this one, related to the condition of "leakage" has been reported from 2013 to a 04/28/2015.Approximately (b)(4) units of the catalog 1517079 has been released since 2013 until 04/28/2015, resulting in a complaint occurrence rate of approximately 0.03 percent.Conclusion: no root cause could be determined as the alleged failure could not be duplicated.

• Brand Name: SELECTOR STERILE TUBING KIT (10)
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP104 DR; UK SP104DR
• Manufacturer Contact: linda serentino ; 315 enterprise drive; 6099365560
• MDR Report Key: 4723728
• MDR Text Key: 17215685
• Report Number: 8010219-2015-00008
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021989
• 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: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1517079
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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