MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL S. L. R. HEATED HI-FLOW INSUFFL TUBING; TUBING/TUBING W/FILTER INSUFFLAT LAP

Catalog Number 28-0212H

Device Problems Kinked (1339); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

The insufflation tubing had a "kink" in the tubing, causing a "blockage" of the co2 gas needed to inflate the abdomen.Therefore, not enough gas was passing through.

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.Original report indicated pictures of the kinked tubing were received and evaluated.It was determined the cause of the kinking was due to the packaging method used.Corrective action and/or systemic correction action taken: a new packaging method was developed to help in the prevention of kinking of the tubing.The new method packaging will consist in coiling and pieces in a more circular way rather than a previous oval used to be packed these tubing; in addition,k a new paper band will hold the tubing in a different manner as well.Preventive action: the process in which the device is being coiled has been updated and a change has been made to the bom for an alternate band.No further info available at this time.The investigation is complete.

• Brand Name: HEATED HI-FLOW INSUFFL TUBING
• Type of Device: TUBING/TUBING W/FILTER INSUFFLAT LAP
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL S. L. R.; km7, autopista joaquin balaquer,; pisano free zone, bldg 49; santiago ; DR
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 4762391
• MDR Text Key: 18289175
• Report Number: 3004605321-2015-00012
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-0212H
• Device Lot Number: 35640366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2014
• Event Location: Hospital
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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