MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.L. R ,KMS, AUTOPISTA JOAQUIN BALAGUER HEATED HI-FLOW INSFFULATION TUBING; INSUFFLATON TUBING, TBING W/ FILTER

Catalog Number 28-0212H

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 03/21/2012

Event Type  malfunction  

Event Description

Customer contacted deroyal sales rep and stated that the tubing "would not flow".

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 information which changes the content of this report.The original root cause was determined to be migration of the plasticizer into the filter housing.It was determined to change the filter material to a polycarbonate material which is stronger, higher impact, and more chemical resistant.It is also less affected by temperature.

• Brand Name: HEATED HI-FLOW INSFFULATION TUBING
• Type of Device: INSUFFLATON TUBING, TBING W/ FILTER
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.L. R ,KMS, AUTOPISTA JOAQUIN BALAGUER; pisano free zone; building 49; santiago ; DR
• Manufacturer Contact: 200 debusk lane; powell, TN ; 8653626157
• MDR Report Key: 4759429
• MDR Text Key: 5954468
• Report Number: 3004605321-2015-00008
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• 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: 05/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-0212H
• Device Lot Number: 25356901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2012
• Event Location: Hospital
• Date Manufacturer Received: 03/27/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Removal/Correction Number: Z-2113-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Other