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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ENTRFLX 8FR;43INW/STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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COVIDIEN ENTRFLX 8FR;43INW/STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 8884720858
Medical Device Problem Codes Complete Blockage (1094); Fluid/Blood Leak (1250); Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/16/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event or Problem Description
The customer reports that they passed the nasoenteral tube and then tested it but during the test they noticed it did not work due to an occlusion.Upon removal of the ng tube, bending/kink was noticed about 5cm from the lead causing the obstruction.
 
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Brand Name
ENTRFLX 8FR;43INW/STYLTY SITE
Common Device Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key8616214
Report Number9612030-2019-02178
Device Sequence Number16899018
Product Code KNT
UDI-Device Identifier10884521518858
UDI-Public10884521518858
Combination Product (Y/N)N
Initial Reporter CountryBR
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8884720858
Device Catalogue Number8884720858
Device Lot Number534982864X
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/10/2019
Initial Report FDA Received Date05/16/2019
Patient Sequence Number1
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