MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.L.R. KM7 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 12/02/2014

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

Investigation findings: when the report was initially received it was determined that a joint investigation with branch plant 65 would be required.The complaint was forwarded to the qc for the joint investigation.Upon completion of the qc investigation the call was returned to the qc complaint specialist.When the joint investigation was received by the qc complaint specialist additional information was requested to complete the investigation process.The additional information was received and the evidence of the training and eco was attached to the complaint file.Correction: replacements have been provided on order # 3498931.Root cause analysis: pictures of the kinked was received and evaluated by qc manager besides a meeting was held to address the issue with the following personnel: sales representative, senior qa manager, packaging engineer, director of manufacturing international operations among others; the conclusion as to why pieces got kinked was basically due to the packing method used.Corrective action and/or systemic correction action taken: a new packaging method was developed to help in the prevention of kink on the tubing.The new method packaging will consist in coiling the pieces in a more circular way rather than a previous oval used to be packed these tubing; besides a new paper band will hold the tubing in a different manner as well.Refer to the coileo attachment for training documentation of the new coiling method and eco 39798 summary attachment as evidence of the band change.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.Refer to the eco 39798 summary attachment.No further information 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 balaguer; pisano free zone, bldg 49; santiago ; DR
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4688224
• MDR Text Key: 5716132
• Report Number: 3004605321-2015-00006
• 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: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2019
• Device Catalogue Number: 28-0212H
• Device Lot Number: 36645741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2014
• 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