MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S. L. R. TUBING, INSU W/ .1 NICR FILT, ECONOMY NS; INSUFFLATION TUBING, TUBING W/FILTER

Catalog Number 28-0207NS

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)

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

Event Date 05/16/2013

Event Type  malfunction  

Event Description

Customer reported that the filter of the insufflation system is blocked.

Manufacturer Narrative

This report is being filed due to a retrospective review of complaints.This complaint has been re-opened for further investigation.A supplemental report will be filed if further investigation provides info which changes the content of this report.Comparative eval of flow rate of insufflation tubing sets demonstrated that the flow rates for all the tubing sets under test were "identical", including the returned set.Any perceived significant flow reduction in the returned tubing set when being used in the field must have been due to other causes and not due to any deficiencies or obstructions in the tubing set components.

• Brand Name: TUBING, INSU W/ .1 NICR FILT, ECONOMY NS
• Type of Device: INSUFFLATION TUBING, TUBING W/FILTER
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S. L. R.; km 7, autopista joaquin balaquer; pisano free zon, bldg 49; santiago ; DR
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 4762389
• MDR Text Key: 5791384
• Report Number: 3004605321-2015-00010
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-0207NS
• Device Lot Number: 28508455
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2013
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/16/2013
• Date Manufacturer Received: 05/16/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2011
• 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 Outcome(s): Other