Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH, INC. MIC TRANSGASTRIC - JEJUNAL FEEDING TUBE KIT; ENTERAL FEEDING TUBE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HALYARD HEALTH, INC. MIC TRANSGASTRIC - JEJUNAL FEEDING TUBE KIT; ENTERAL FEEDING TUBE Back to Search Results
Model Number 0250-22
Device Problems Hole In Material (1293); Leak/Splash (1354); Occlusion Within Device (1423)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
This is the first of three reports for the same patient involving three separate products.Refer to manufacturer report number 9611594-2014-00158 for the second report.Refer to manufacturer report number 9611594-2014-00157 for the third report.It was reported by a nurse that a patient experienced three enteral feeding tube device failures within three months.Each enteral feeding tube lasted a month before it developed a pinhole and leaked.The hole was usually on the j-portion of the enteral feeding tube.The nursing staff states that the tubes will usually clog prior to failure.The patient was getting continuous feedings with an additional bag of water to flush the tube every six hours.The staff was crushing the medications prior to infusing in the enteral feeding tube.The nurses have started using a lipase enzyme in the enteral feeding tube to prevent clogging of the tube.According to the nurse, the lipase enzyme will prevent clogging of the tube until the hole develops and the tube fails.There was no reported patient injury but the patient required medical intervention to replace the tube under fluoroscopy.The stoma site remained open and intact at the time of the event.No additional information was provided in regards to the patient's status and the outcome of the procedure.
 
Manufacturer Narrative
(b)(4).Evaluation of the returned complaint product is in-progress.A review of the device history record is not possible as no lot number was provided.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MIC TRANSGASTRIC - JEJUNAL FEEDING TUBE KIT
Type of Device
ENTERAL FEEDING TUBE
Manufacturer (Section D)
HALYARD HEALTH, INC.
alpharetta GA 30004
Manufacturer (Section G)
AVENT SA DE R.L. DE C.V.
circuito industial no.40
colonia obrera
nogales, sonora 8404 8
MX   84048
Manufacturer Contact
lisa clark
5405 windward pkwy
alpharetta, GA 30004
MDR Report Key4289058
MDR Text Key20457748
Report Number9611594-2014-00156
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K926581
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0250-22
Device Catalogue Number991095487
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/03/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age49 YR
Patient Weight40
-
-