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Adverse Event Report

BALLARD MEDICAL PRODUCTS MIC TRANSGASTRIC JEJUNAL FEEDING TUBE ENTERAL FEEDING TUBE   back to search results
Event Date 11/24/1998
Event Type  Death   Patient Outcome  Death;
Event Description

In 1998, a 17-month-old male with multiple congenital anomalies and internal and external malformations had the mfr's transgastric jejunal (tj) tube placed to help eliminate gastric reflux and to promote weight gain. The tube was placed through an existing gastrostomy site under fluoroscopic guidance with a guide wire. Contrast medium was instilled through the tube to confirm placement. Approx 4 hours after tube placement the child began to display signs of discomfort and irritability. On the following day, the parents returned with the child to the hospital. Tube placement was again verified under fluoroscopy. In 1998, the home nurse reported to the parents that the child was pale in the lips and was experiencing respiratory distress. The child was returned to the clinic and the tj tube was removed and the mfr's skin level feeding tube was inserted. The physician recommended that the child be taken to the local hospital. One hour later the child was admitted to the hospital with fever, paleness, and tachycardia. The following morning, the physicians recommended that the child be transported to the hospital due to a drop in critical lab values. At 11:42 am it was reported that the child had an onset of significant bradycardia and code blue was called. Resuscitative efforts continued for two hours but the child died at 1:45 pm.

 
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Brand NameMIC TRANSGASTRIC JEJUNAL FEEDING TUBE
Type of DeviceENTERAL FEEDING TUBE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BALLARD MEDICAL PRODUCTS
12050 lone peak pkwy.
draper UT 84020
Manufacturer (Section D)
BALLARD MEDICAL PRODUCTS
12050 lone peak pkwy.
draper UT 84020
Manufacturer (Section G)
BALLARD MEDICAL PRODUCTS
1999 alvin ricken dr
pocatello ID 83201
Manufacturer Contact
e. chamberlain, ph.d.
12050 lone peak pkwy
draper , UT 84020
(801) 572 -6800
Device Event Key249137
MDR Report Key257271
Event Key241140
Report Number1719891-1999-00020
Device Sequence Number1
Product CodeKNT
Report Source Manufacturer
Source Type Other
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 12/29/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/1998
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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