MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.L.R KM7 TUBING, INSUFFLATION 2/ .3 MICR FILT/STRYKER AD; INSUFFLATION TUBING, TBING W/ FILTER

Catalog Number 28-0211

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2013

Event Type  malfunction  

Event Description

Customer reported that the tubing started leaking around the end that plugs into the machine.After follow up with customer, it was reported that the leak occurred towards the middle of the filter housing, but not visual damage to the product was found.

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 could not be determined since no sample was returned and no remaining inventory of provided lot was available.The original investigation concluded that this could have been an isolated incident since other work orders produced using the same lot of filters were reviewed adn not complaints of leaking were reported.

• Brand Name: TUBING, INSUFFLATION 2/ .3 MICR FILT/STRYKER AD
• Type of Device: INSUFFLATION TUBING, TBING W/ FILTER
• 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 ; 8653626157
• MDR Report Key: 4759426
• MDR Text Key: 5794090
• Report Number: 3004605321-2015-00009
• 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 Health Care Professional
• 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: 28-0211
• Device Lot Number: 27033662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2013
• Event Location: Hospital
• Date Manufacturer Received: 02/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2012
• 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