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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH, INC. MIC GJ TUBE TUBE, GASTRO-ENTEROSTOMY
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HALYARD HEALTH, INC. MIC GJ TUBE TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Catalog Number 0250-22
Device Problems Leak/Splash (1354); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2019
Event Type  malfunction  
Event Description
Pt has gastrostomy-jejunostomy (gj) tube that is leaking at the connection site to the tube feeds. Have tried multiple adapters but have been unsuccessful in correcting the problem. Escalation continuing. Finally cardiovascular and interventional radiology (cvir) came to look at gj. Cleaned interior surface with q-tip and gj was then able to "lock" into place without leaking. Per cvir - if this does not continue to work may need to replace. These are supposed to "lock" into place with a little turn/twist of the gj adaptor but they do not always work. Presently not leaking.
 
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Brand NameMIC GJ TUBE
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
HALYARD HEALTH, INC.
5405 windward parkway
3rd floor west
alpharetta GA 30004
MDR Report Key8585876
MDR Text Key144265346
Report Number8585876
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0250-22
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2019
Event Location Hospital
Date Report to Manufacturer05/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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